VRX - Valeant Pharmaceuticals International Inc.

[scorpioncapital]

I'm always amazed how investors flock to the fire and tempted by a low price. No price is low enough for a less than honest management. Even if the stock triples from here it would not be a good process. The key is to know what to stay away from regardless of the returns available. Returns are like carrots dangling from sticks. Here's a better strategy: Find an adjacent carrot. Like perhaps one of the many pharmas in this space that are somewhat better if you have to be in it at all. Maybe Endo is an example. I found a few opportunities in the space from this spill out but not necessarily legacy generic pharma in run-off.

[Liberty]

That said, I am not convinced Valeant mgmt did not know what was going on a Philidor. I would be surprised if it made it all the way to the c-suite though. We have all said that the bet has been on Pearson being honest. If we are wrong on that, we will be wrong on this investment. If middle management at Valeant is involved, I maintain fines will not be larger than .5 billion and definitely not more than $1B with my most likely scenario low 100 millions.

OM, I don't see why it's hard to believe that the goings on at Philidor were known to the c-suite. It's obvious that the reason for Philidor was to be aggressive in filling prescriptions with Valeant drugs. Valeant paid 100 million for control of Philidor. That amount of money must get approval from the CEO. So it looks like the C-suite was aware.

 

There's a difference between the C-suite being aware of the deal with Philidor and of Philidor's existence, and possibly of aggressive but legal practices, and being aware of anything illegal going on at Philidor.

 

If you're Andrew Davenport and Valeant buys you out but then leaves you to operate mostly on your own, and you have 100m+ in additional earnouts coming if you can meet certain targets, if you're a crook, it's possible that you could devise a way to juice results to meet those targets in a way that PBMs and VRX don't find out (at least over the short exitence of Philidor.. it's not like this has been going on for years).

[original mungerville]

For all we know, Monday could be a moment where some uncomfortable whistle-blower employees have anonymously tipped off Citron with internal company documents or emails.  Could be about unsavory buried science regarding their drug development labs, or documented internal discussion about Philidor ("we're going to knife the baby!" type stupid comments). 

 

I mean... this would be the time when a person in search of a voice would come forward and Citron could be their mouthpiece.

 

Just wondering how he could suddenly have more supposedly damning info already.  He can't come out with complete bullshit, it's got to be some kind of company document or testimonial from an internal source.  He's already been referred by Valeant to the SEC so his lawyers would likely be making sure he has something real -- or would he ask his counsel first?

 

Yup, should be interesting. This is a pretty binary investment. If all Citron comes out with on Monday is whistleblowers that make clear middle management knew, that is not necessarily enough. I have been expecting Valeant to not be clean on this. If it goes to Pearson, that's another thing though. The board is going to be pissed.

[tylerdurden]

Oh come on are you serious? That's ridiculous! There is lots of evidence that they were running the operations of Philidor even if they didn't TECHNICALLY own it. The name alone (chess reference) makes it entirely obvious.

 

If you have (former?) employees working there, "joint steering committee" etc, and an OPTION STRUCK AT ZERO DOLLARS, then you are running that business. It is as simple as that.

 

The only reason to use an option struck at zero and not make an outright purchase is if you are trying to hide ownership from someone. If you say anything else you are totally deluded. Wake up from your slumber here and see the light of day.

 

The important question is materiality-- what's the actual effect on the business. Still ZERO people have tried to actually lay out all the ways Valeants products are distributed and try to see which ones could be affected.

 

I'll give you a start-- contact lenses are probably not affected. Sales through wholesalers and then through retail are probably not affected. I believe that already accounts for the majority of US sales. What about the rest? What about Europe?

 

I'm not saying they didn't have ultimate control over the entity's destiny. I'm saying that it's one thing to have high level, strategic control (of the kind of "we should get distribution in states X, Y and Z... we will invest in more staff to add two new products in 6 months...") and to have day-to-day control over how employees are trained, how they're told to fill out form, compliance, etc.

 

Maybe Valeant knew about everything and told them to do it. I don't know. But I think it's also plausible that Philidor management committed fraud to get their earnouts without the knowledge of Valeant. The net worth of Andrew Davenport and his cronies might double if they get those earnouts, so that's certainly an incentive for someone unscrupulous. But Valeant was doing quite well long before Philidor was ever on the scene, these tactics were worth at most a couple points of growth (I'm sure a lot of the 6-7% was legit, and if Philidor hadn't existed, it would've gone through other channels -- after all, doctors do prescribe the stuff), and the downside is huge...

 

So maybe they did it, I don't know. But I think right now a lot of people are ready to put handcuffs on management with very few hard facts.

 

My impression from WSJ/Bloomberg articles is that Philidor training materials have VRX products explicitly defined and tell employees how not to take no for an answer. Anyways no one can say 100% for sure but my gut says they were pretty much involved in day to day operations.

 

It seems VRX was doing fine before Philidor but wasn't Philidor still one of the key component of their growth story? Don't know, perhaps they were out of options with acquisitions etc. so Philidor was the next big thing for them...

[cmlber]

 

 

Tombgrt,

 

I am glad we are amusing for you.

 

That said, I am not convinced Valeant mgmt did not know what was going on a Philidor. I would be surprised if it made it all the way to the c-suite though. We have all said that the bet has been on Pearson being honest. If we are wrong on that, we will be wrong on this investment. If middle management at Valeant is involved, I maintain fines will not be larger than .5 billion and definitely not more than $1B with my most likely scenario low 100 millions.

 

I know hard to quantify at this point but hard for me to believe the legal fine would be the only financial impact on VRX.

 

Only financial impact? No, 5% of sales are gone, a % of ongoing growth is gone. Furthermore, their debt is more expensive to issue, and 50 billion plus of market cap is gone. And that assumes there are no more cockroaches.

 

That's one way of looking at it.  On the other hand, they won't be doing any acquisitions soon anyways so don't need to tap the debt markets in the short term, so I'd frame it as their debt is now cheaper to repay.  They can deliver much more rapidly when their debt trades at a 10-15% discount to par.

 

There is $61 billion in enterprise value right now.  Let's say a fair multiple on whatever cash flow there is when this storm passes is 15x unlevered free cash flow.  I think a discount to the levered market multiple is fairly conservative for an industry that typically trades at a premium to the market on levered earnings.  So to make this valuation fair, you need $4 billion in free cash flow unlevered.  With the tax rate and low capex requirements, that means you need about $4.5 billion in EBITDA. That's a 40% discount to guidance. Philidor is 7% of sales and a lot of that will just get diverted to other channels.

 

Even if Pearson is found to be personally involved in Philidor, who cares at $90?

 

But I highly doubt there will be any smoking gun evidence that Pearson was involved.  A) because his incentives give him no reason to engage in fraud to boost short term results and B) because even if he was stupid enough  to do it you also need to believe he was stupid enough to commit fraud in a way that could be traced back to him.  We'll see on Monday.

[rb]

That said, I am not convinced Valeant mgmt did not know what was going on a Philidor. I would be surprised if it made it all the way to the c-suite though. We have all said that the bet has been on Pearson being honest. If we are wrong on that, we will be wrong on this investment. If middle management at Valeant is involved, I maintain fines will not be larger than .5 billion and definitely not more than $1B with my most likely scenario low 100 millions.

OM, I don't see why it's hard to believe that the goings on at Philidor were known to the c-suite. It's obvious that the reason for Philidor was to be aggressive in filling prescriptions with Valeant drugs. Valeant paid 100 million for control of Philidor. That amount of money must get approval from the CEO. So it looks like the C-suite was aware.

 

There's a difference between the C-suite being aware of the deal with Philidor and of Philidor's existence, and possibly of aggressive but legal practices, and being aware of anything illegal going on at Philidor.

 

If you're Andrew Davenport and Valeant buys you out but then leaves you to operate mostly on your own, and you have 100m+ in additional earnouts coming if you can meet certain targets, if you're a crook, it's possible that you could devise a way to juice results to meet those targets in a way that PBMs and VRX don't find out (at least over the short exitence of Philidor.. it's not like this has been going on for years).

Liberty, you may believe whatever you want. It seems that whenever there's any question raised about Valeant you always come out strongly in favour of VRX management. A week or so ago you were sure that nothing wrong was going on at Philidor. Now you seem pretty sure that C-suite didn't know anything about the wrong doing. So I don't know if you are or can be objective in your view of Valeant.

 

Valeant is a company that is ultra-aggressive in pushing their drugs and making numbers, always going right to the line of what they can do and what's legal. In an environment like that is very easy to go over the line. That's why it's not hard to believe that top management knew or sanctioned it as opposed to some rogue middle manager. Also this totally looks like something that Valeant would do.

[original mungerville]

How do you show negative growth when 7% of sales, at most, are gone. Ackman says only half of that 7% will be gone as Valeant drugs previously at Philidor will go through other channels. My take is, Philidor probably juiced things more than that, so I would say only one quarter of that 7% will remain, so about 2% remains and therefore a 5% loss in sales. Cash EPS declines to $14. (For example, Jublia is growing even without Philidor. Studies show it is at least 50% more effective than Lamisil (ie 15-20% effectiveness vs 10%) and so doctors like recommending it. If you ask me, none of those products work but at this point, they are the best options unless you want to shred your liver taking a pill along with applying these.) How do you get to negative cash EPS just because Philidor is gone?

 

Not saying negative earnings, just a lot less than $16 cash EPS.  And who knows what actual free cash flow will look like relative to cash EPS at this point.

 

They can't show positive growth in US branded anymore, they lost control of being able to refill drugs (big difference between a 2x refill versus 3x or 4x), they can't buy tail assets, they can't raise pricing, etc.  Close to half the portfolio is now at best flat and the rest is under a lot of pressure to perform.  And if indications of channel stuffing at Salix are true, well that's even worse. 

 

I'm sort of curious if there's a specific reason why Salix stuffed the channels to begin with.  Maybe it's something drug/distribution related that didn't show up in models?  I don't know but need to look into it. 

 

Anyway I'm just looking at this from the markets point of view.  Negative growth in half the portfolio means amortization is now a cost.  That's why it's a problem, not so much the fines.

 

So you think they bought Salix after Salix was accused of channel stuffing, and then they stuffed Salix channels? Really? If that is the case, they'll go to jail and deserve it. I don't think they are stuffing Salix channels. The market's view is this is really complicated and it smells really bad, and the current holders are already all-in so they can't double down even if they wanted to. And for anyone to get up to speed in an institutional setting, its going to take months and its going to take putting career at risk.

[Liberty]

Liberty, you may believe whatever you want. It seems that whenever there's any question raised about Valeant you always come out strongly in favour of VRX management. A week or so ago you were sure that nothing wrong was going on at Philidor. Now you seem pretty sure that C-suite didn't know anything about the wrong doing. So I don't know if you are or can be objective in your view of Valeant.

 

A week ago it seemed very likely that the original accusations, which were for channel stuffing and phantom pharmacies with fake sales, were wrong. And apparently they were. This is new stuff.

 

All I'm saying is that there are multiple plausible scenarios. A bunch of people immediately jump on "management knew", and I'm saying that the exact same circumstances that we're seeing right now could have arisen without management knowing.

 

Valeant is a company that is ultra-aggressive in pushing their drugs and making numbers, always going right to the line of what they can do and what's legal. In an environment like that is very easy to go over the line. That's why it's not hard to believe that top management knew or sanctioned it as opposed to some rogue middle manager. Also this totally looks like something that Valeant would do.

 

Maybe. But I think there's a difference between doing something that is clearly fraud - changing doctors prescriptions, if the media reports are accurate - and what I've seen Valeant do so far.

[rpadebet]

Wow. This thread is entertaining for sure. it is growing faster than I can read. If it were a stock, I would put a 50 multiple on the thread given its growth rate.

 

Btw, added a little bit more today. 10% of portfolio now. At close to 1/3 the high, I felt obligated.

 

I am waiting for the inevitable CBS 60mins report, CNBC special and CNN headline to shore up more cash and double my position. It was 20-25% when I sold, so happy to re-establish it at these prices.

 

Here is what i understand. A pharmacy, which they may or may not own legally, might or might not have instructed its employees to grow VRX prescription volume. If the pharmacy didn't instruct, some employees might or might not have done it by themselves anyway. Nothing is proved yet, just alleged. At this price and below the baby is being thrown out with the bath water.

 

Anyway, I think there will be sales impact for a year or so from this before they figure out a newer way to distribute. there might be fines a few years down which will most likely be immaterial. there will be some interesting drama meanwhile for sure. At the end this will be a mature and better company.

 

 

[feynmanresearch]

Wow. This thread is entertaining for sure. it is growing faster than I can read. If it were a stock, I would put a 50 multiple on the thread given its growth rate.

 

Btw, added a little bit more today. 10% of portfolio now. At close to 1/3 the high, I felt obligated.

 

I am waiting for the inevitable CBS 60mins report, CNBC special and CNN headline to shore up more cash and double my position. It was 20-25% when I sold, so happy to re-establish it at these prices.

 

Here is what i understand. A pharmacy, which they may or may not own legally, might or might not have instructed its employees to grow VRX prescription volume. If the pharmacy didn't instruct, some employees might or might not have done it by themselves anyway. Nothing is proved yet, just alleged. At this price and below the baby is being thrown out with the bath water.

 

Anyway, I think there will be sales impact for a year or so from this before they figure out a newer way to distribute. there might be fines a few years down which will most likely be immaterial. there will be some interesting drama meanwhile for sure. At the end this will be a mature and better company.

I think you are underestimating the gravity of this situation

[original mungerville]

What's the gravity of the situation?

 

Unless there is widespread fraud across the whole firm, or Pearson is involved with all the philidor operational details (not sure where he would find the time for that) - what additional facts point to the gravity of the situation?

 

 

[Guest Schwab711]

The issue isn't the fines.  The problem is the long-term affect on their operating business.  Medicis had big problems with Solodyn and other treatments because of the existing distribution method that Valeant likely has to go back to.  That's a bad thing because it's clear that was driving a lot of the organic growth.  The sell side is still saying they'll earn $16 of cash EPS. Throw those earnings out the window now that Philidor is gone.

 

The fines are irrelevant at this point.  What do you think the stock will do if they start showing negative growth?  All of a sudden the amortization is an expense and it's going to snowball.

 

How do you show negative growth when 7% of sales, at most, are gone. Ackman says only half of that 7% will be gone as Valeant drugs previously at Philidor will go through other channels. My take is, Philidor probably juiced things more than that, so I would say only one quarter of that 7% will remain, so about 2% remains and therefore a 5% loss in sales. Cash EPS declines to $14. (For example, Jublia is growing even without Philidor. Studies show it is at least 50% more effective than Lamisil (ie 15-20% effectiveness vs 10%) and so doctors like recommending it. If you ask me, none of those products work but at this point, they are the best options unless you want to shred your liver taking a pill along with applying these.) How do you get to negative cash EPS just because Philidor is gone?

 

7% is YTD. Specialty pharmacies were ~9% of 3Q15 revenue (shows how much faster this revenue stream was growing relative to VRX as a whole). That's a ~$1b run-rate!

 

Neuro/other is 15%. EM (18%) is likely unprofitable and killing their tax structure. A large part of VRX's revenue is under an investigation of some kind!

 

Fines are generally $1,000's/record for unauthorized access. I believe Phildor mentioned they had 2.2m patients in CA (unclear whether they would have direct access to all patient's records). No company has ever been dumb enough to sell drugs at a large-scale without a license (directly or indirectly)! Looking at historical fines in this situation is like comparing B&L to KO.

 

Just to add, the wonderful thing about using "Cash EPS" is it's almost impossible for it to be negative for VRX. Since A + I is so large, it's very likely "Cash EPS" would be positive even if VRX was in bankruptcy.

[original mungerville]

“Everybody was focused on pricing on drugs and, boom -- Philidor -- everyone’s focusing on that,” Left said. “Philidor is in the past, this has nothing to do with Philidor. Let’s look toward the future, look at what they have, what products they have.”

 

So Left doesn't have anything on Philidor. He says he has something else related to the products.

[NeverLoseMoney]

About Sequoia Fund and possible redemptions: one of the two directors who resigned was Sharon Osberg. She's a bridge partner and close friend of Warren Buffett. According to the WSJ article she had expressed concerns about the size of Sequoia's VRX position in recent months.

 

This is speculation from my side, but it doesn't seem like a crazy assumption that Osberg asked Buffett for some advice here before resigning.

 

Even if this turns out not to be the case, if I were a Sequoia investor it would make me uncomfortable that Osberg resigned. I don't know if many investors are still in there that originally followed Buffett's endorsement of the fund, but I wouldn't be surprised to see major redemptions.

[tylerdurden]

What's the gravity of the situation?

 

Unless there is widespread fraud across the whole firm, or Pearson is involved with all the philidor operational details (not sure where he would find the time for that) - what additional facts point to the gravity of the situation?

 

What about the impact on other businesses/products and their business model (relations with payors, doctors etc.)? I don't know.

[ERICOPOLY]

“Everybody was focused on pricing on drugs and, boom -- Philidor -- everyone’s focusing on that,” Left said. “Philidor is in the past, this has nothing to do with Philidor. Let’s look toward the future, look at what they have, what products they have.”

 

So Left doesn't have anything on Philidor. He says he has something else related to the products.

 

Valeant must have pissed off A LOT of current and former employees with their actions cutting R&D.  Many of those people are very ethical scientist granola types that would have felt very conflicted about seeing their research and hard work to make people's lives better through science, only to see their work bought by hedge fund billionaires who jacked up prices to hurt the patients they were trying to help.

 

So Valeant management if they slipped up in any way ethically and did it in front of those people in any kind of documentable way... they've got a lot of people who would love to see them fall.  And there's much to speculate (they play too close to the line) that they've behaved in ways that look VERY unethical on the front page. 

 

Lot's of enemies and questionable ethics.  There's potential here for an embarrassing internal anonymous disclosure.

 

 

[Picasso]

About Sequoia Fund and possible redemptions: one of the two directors who resigned was Sharon Osberg. She's a bridge partner and close friend of Warren Buffett. According to the WSJ article she had expressed concerns about the size of Sequoia's VRX position in recent months.

 

This is speculation from my side, but it doesn't seem like a crazy assumption that Osberg asked Buffett for some advice here before resigning.

 

Even if this turns out not to be the case, if I were a Sequoia investor it would make me uncomfortable that Osberg resigned. I don't know if many investors are still in there that originally followed Buffett's endorsement of the fund, but I wouldn't be surprised to see major redemptions.

 

Interesting note, thanks.

[rpadebet]

Wow. This thread is entertaining for sure. it is growing faster than I can read. If it were a stock, I would put a 50 multiple on the thread given its growth rate.

 

Btw, added a little bit more today. 10% of portfolio now. At close to 1/3 the high, I felt obligated.

 

I am waiting for the inevitable CBS 60mins report, CNBC special and CNN headline to shore up more cash and double my position. It was 20-25% when I sold, so happy to re-establish it at these prices.

 

Here is what i understand. A pharmacy, which they may or may not own legally, might or might not have instructed its employees to grow VRX prescription volume. If the pharmacy didn't instruct, some employees might or might not have done it by themselves anyway. Nothing is proved yet, just alleged. At this price and below the baby is being thrown out with the bath water.

 

Anyway, I think there will be sales impact for a year or so from this before they figure out a newer way to distribute. there might be fines a few years down which will most likely be immaterial. there will be some interesting drama meanwhile for sure. At the end this will be a mature and better company.

I think you are underestimating the gravity of this situation

 

Maybe I am underestimating it again ;). I had similar responses from gio and others in August.

Here is what I thought then and think now, I don't know if it is a fraud. I am pretty sure the management has been aggressive until now promoting the business.

 

Business is inherently messy. Future wasn't totally bright and rosy as it appeared in August and it isn't totally grim and dark as it appears now.

 

VRX is like that teenager who attained stardom too soon, couldn't handle the fame and got caught in a DUI by the paparazzi.

 

The board and large investors here are adults. I am sure they will take charge and fix the issues here. It will take some time and it will be tough, but the company will be better off for it.

 

The underlying business assets and business economics are sound. There appear to be some problems with the processes. the model they used until now, debt fueled acquisitions, is all but done for a while.

 

I agree with others, $16 cash eps is a bye bye for now. Revenue will surely take a 10-20% hit until they figure their way around it.

 

But here is the attraction at this price- they don't need that 20% organic growth and can get off the 20% IRR treadmill given all that has happened. It was getting tough to do that anyway.

[ourkid8]

Why didn't she raise concerns with the huge position in Berkshire before it was reduced? Why didn't she have concerns over the summer on the size of the position?

 

Next, asking Buffett? Buffett has always taken concentrated bets, Amex/Geico and you can name many others. Come on guys, let's stop speculating on things that don't make much sense. 

 

About Sequoia Fund and possible redemptions: one of the two directors who resigned was Sharon Osberg. She's a bridge partner and close friend of Warren Buffett. According to the WSJ article she had expressed concerns about the size of Sequoia's VRX position in recent months.

[wisdom]

It looks like people are getting carried away and think the whole company is a fraud based on one pharmacy that they did not even own.

 

Lot's of speculation but very few facts being talked about.

[rpadebet]

“Everybody was focused on pricing on drugs and, boom -- Philidor -- everyone’s focusing on that,” Left said. “Philidor is in the past, this has nothing to do with Philidor. Let’s look toward the future, look at what they have, what products they have.”

 

So Left doesn't have anything on Philidor. He says he has something else related to the products.

 

Ha ha ,

On my way home from work, I was thinking what story would I like if I were a short. I think a truly sensational story here would do the trick. What can such a story be....

 

 

My guess,

Suburban single mom with two kids living paycheck to paycheck. Goes through a bad period in life and ends up with a prescription for some neuro drug or God forbid toe nail fungus.

 

She gets dumped with these medicines for free or very low cost. In an effort to better her life and thus her children's,she decides to use the toe nail cream liberally.

 

At the end of the story, she loses her toe or something to that effect. The scene now cuts to fat and snobby Pearson and VRX with big bad hedge fund investors like Ackman partying.

 

 

Even I can produce a CBS 60 minutes story based of this...

 

I hope this gets us to $60-$70 a share within next few weeks.

[S2S]

Valeant must have pissed off A LOT of current and former employees with their actions cutting R&D.  Many of those people are very ethical scientist granola types that would have felt very conflicted about seeing their research and hard work to make people's lives better through science, only to see their work bought by hedge fund billionaires who jacked up prices to hurt the patients they were trying to help.

 

So Valeant management if they slipped up in any way ethically and did it in front of those people in any kind of documentable way... they've got a lot of people who would love to see them fall.  And there's much to speculate (they play too close to the line) that they've behaved in ways that look VERY unethical on the front page. 

 

Lot's of enemies and questionable ethics.  There's potential here for an embarrassing internal anonymous disclosure.

 

Good comment. I'd add that, from a few calls we've made, even former VRX employees on the business side have not nice things to say about the company.

[ourkid8]

AGREED! The optics looks terrible but based on many experts, VRX did not break the law. Let's not get carried away and feed into this frenzy going on.

 

It looks like people are getting carried away and think the whole company is a fraud based on one pharmacy that they did not even own.

 

Lot's of speculation but very few facts being talked about.

[rb]

Why didn't she raise concerns with the huge position in Berkshire before it was reduced? Why didn't she have concerns over the summer on the size of the position?

 

Next, asking Buffett? Buffett has always taken concentrated bets, Amex/Geico and you can name many others. Come on guys, let's stop speculating on things that don't make much sense. 

 

About Sequoia Fund and possible redemptions: one of the two directors who resigned was Sharon Osberg. She's a bridge partner and close friend of Warren Buffett. According to the WSJ article she had expressed concerns about the size of Sequoia's VRX position in recent months.

Well maybe why she didn't have a problem with Sequoia's large BRK position is that BRK is very different than VRX. Strong balance sheet, diversified, highly ethical management, conservative accounting, etc. Basically almost the complete opposite of VRX.

[ERICOPOLY]

“Everybody was focused on pricing on drugs and, boom -- Philidor -- everyone’s focusing on that,” Left said. “Philidor is in the past, this has nothing to do with Philidor. Let’s look toward the future, look at what they have, what products they have.”

 

So Left doesn't have anything on Philidor. He says he has something else related to the products.

 

Ha ha ,

On my way home from work, I was thinking what story would I like if I were a short. I think a truly sensational story here would do the trick. What can such a story be....

 

 

My guess,

Suburban single mom with two kids living paycheck to paycheck. Goes through a bad period in life and ends up with a prescription for some neuro drug or God forbid toe nail fungus.

 

She gets dumped with these medicines for free or very low cost. In an effort to better her life and thus her children's,she decides to use the toe nail cream liberally.

 

At the end of the story, she loses her toe or something to that effect. The scene now cuts to fat and snobby Pearson and VRX with big bad hedge fund investors like Ackman partying.

 

 

Even I can produce a CBS 60 minutes story based of this...

 

I hope this gets us to $60-$70 a share within next few weeks.

 

That might be a good best case scenario.  A good worst case scenario would be faking data presented to the FDA.