Quiz answer:

A) The indication. In the video, it says "creases and wrinkles around the mouth". This is broader than the actual indication of nasolabial fold winkles.

B) The whole "natural is better" BS. First, it is not 100% from the patient (see the label reference below). Second, the other leading treatments are also "natural".

I would also take issue with the argument that "natural" implies "safer" is obviously garbage, but that may or may not be considered a factual claim.

As to LaViv being natural:

Not just I-Hub, many are now doing this.

I am reasonable certain I will sell my SGEN shares at the open on July 11th to be ahead of the crowd.

[I like SGEN, but SGEN-35 is a small piece adn I suspect the "play the FDA" crowd will overplay it]

ITT or modified ITT, just words here.

The patients that missed treatment did not do so because of any situation that would come up in actual use, they did so solely because of the FDA action.

This clearly differs from the standard justification of ITT, that patients who do not complete treatment will reflect the actual real use of the drug and therefore must be included.

One would hope that the decision to replace was made very early before there could be much of any hint of it being a results driven decision.

P.S., the theory from Yahoo that hirogen skeptically relayed, that only the treatment arm would be replaced, is irrational. It does not just break the randomization in some technical way, you would have clear biases that would be introduced by the time shift of part of one arm. The strongest would be better supportive care being introduced in the intervening years (it is OS after all).

Re: MNTA partner for FoBs

Could somebody explain why it is obvious they need a partner for all programs?

Seams like they could easily get the ABLA (or whatever it is called) in front of the FDA. If the FDA decides that it is well characterised and only needs minimal trials, then I would think MNTA could also handle this.

If it gets approved as substitutable, then all they need is somebody who gets a modest cut for handling the mechanics of getting it out.

So, is it not possible they could push some candidates forward before they have a partner?

EDIT: Especially as it becomes more clear that TEVA's "next month" claim for tL meant July of some year.

Very possibly the FDA either considered it obvious, or considered it an insignificant change. Else why would they allow the change?

The argument for obviousness is this. The earlier invention already lowed the MW by removing much of the higher MW species. I would presume this was done for exactly the reason in the example rat study you note. If the higher MW weight species were causing AEs, then one would assume that a better job of removing them would be good.

Did the FDA accept the change because it was obvious that the change would be good as it removed unwanted contaminates?

Alternatively, the product is the same and all that happened was that they tightened up the process to make a more consistent product.

Did he FDA accept the change because there was no real change in the product?. If so though, then the CoM patents are likely double patenting.

So you have 2 very real possibilities that the info contained in the FDA documents will through serious doubt on the patents validity.

Come on man, throw us a bone and give us at least 5% and I will drop the issue

On a non-patent note, that the new MW was accepted by the FDA goes against TEVA's argument that Copaxone can not be duplicated because nobody knows what it is. "Obviously" the FDA did allow a change to it, with (presumably) far less documentation on it being the same than that which MNTA/Sandoz is providing.

The overall effect will be the opposite, you will get more late data than otherwise expected.

The early events from the post-hold patients would have been on the curve anyway. The difference (as slight as it might be) is that you get some more late events from the pre-hold group (should be obvious), and more early time based censors on the post-hold group (as the trial will end sooner for them).

You are making an assumption that the lower MW truly is safer, not just another colour.

If I patent a blue wonder hammer, then later try to extend the term by patenting a pink version with the claim that it strikes harder, we have an issue.

Could you extend the patent forever just by changing colours?

Did TEVA really make a better version, or just change the colour?

TEVA told the FDA that the product was the same wrt safety and efficacy.

Copax trials odds.

I would like to change my estimates to :

For the CoM patents

Obviousness, double patenting, etc. : 40%
Non-infringement : 20%
Indefiniteness/Best Practice/Enablement : 5%
Inequitable conduct : 30%.

For the rest:

Obviousness etc. : 0%
Non-infringement : 80%
Indefiniteness : 10%
Inequitable conduct : 0%.


That comes out to 67% on the CoMs and 82% on the process patents, 55% overall.

I still think this is for entertainment value only. The FDA action dominates the valuation.

Mouton, could you clarify a few points?

I assumed that the "but for" rule was that the patent MIGHT not have been approved "but for" the issue at hand. Is it "might" or "would"?

Even w/o that though, if the facts are that TEVA told the PTO "this (MW change) is better" while telling the FDA "this is the same", then I would consider that egregious conduct.

No, it does not.

IC means that the applicant was not playing fair with the PTO. It does not require that the patent would not have been granted anyway.

The concept is that the PTO is not being adversarial in the process, so when the applicant is not being straight up, that is inequitable (in the sense that the PTO is being fair and balanced, while the applicant is not).

The recent ruling that changed the standard some means that the IC has to be more significant wrt the patent being granted, but not that it was necessary.

BTW, IC does not invalidate the patent, it makes it unenforceable. I have no idea if this makes any real world difference.

As to your reply to North's #2, the reason for that being a possibility is exactly what happened in the example case he gave in #1, namely that 2 separate appeals were needed. I am with you that this is "wrong" (costing the parties time to possibly save some bench costs), but I would certainly see why it is possible.

And certainly believe North on the issue.

Regardless, I like the early action on this. I do not see why the change in the court logic really hits this very hard, clearly the issues seams to play into the PTO decision.

And how many just flame out as expected?

Care to bet on Pixantrone next year?

I would assume the vast majority of summary judgement motions are denied for exactly this reason (facts are in dispute), and it can almost be a form reply.

This differs from rejecting a PI where more information might come out. Example, SFA vs. FDA in the mL suit where the Judge clearly sided with the FDA as he discussed the odds of SFA winning the final decision.

If so, then why should it be it be approved based on lowering TGs?

The Burzynski story sounds like it should be for the DNDN crowd.

As a legal side note, I believe the US Gov has the ability to make use of any US patent w/o regard to the assignees rights.

And the good doctor always had a very easy solution to his predicament, just go south of the boarder.Obviously all he was interested in was running a cancer cure scam, it would seam easier from there.

[If anyone actually believes he was in this for the good of humanity, all he had to do was find any biotech with some resources to get the ball going.]

Could you clarify the question as to who the suspected scam party is?

A) The Tibetan company actually doing some business selling whatever (of which there is no actual ownership interest by the corporation)?

B) The "management company" in Shenzhen that collects the profits from A via a series of contracts (that are presumably between the exact same parties on both sides)?

C) The Hong Kong company that is a pure shell around B and exists for no obvious reason?

D) The British Virgin Island corporation that is just a shell around C and exists in order to be a public company?

E) The largest customer of A (which just happens to be owned by the CoB)?

F) All of the above.

I believe it is an NDA, this is the synthetic "Lovenox" right? Certainy a new drug.

Or else I am just up past my bedtime.

OK, I am an idiot. For some reason I thought this drug had never been approved in the US.

Priority reviews are part of the PDUFA act that applies to NDA/BLAs, but not ANDAs.

Promise?

I would love to pick up another few shares of CAT at under $30

I thought it was hard to tell during the Nimzo period, as they could excuse a lot of what looked odd to the US Cuban issue.

But this time there is another more real concern, namely the hyping of 2 drugs that they picked up for a combined $15M by buying Cytopia. Both drugs were already in the clinic, yet Cytopia sold for pocket change.

It's not like they bought some random pre-clinical drugs and they latter turned valuable. They bought the for $15M outright and were immediately positioning them as the great white hope.

"from CoM patent standpoint, I think it is still infringing...because it is a patent on the end product or its specification. From a process standpoint, it is non-infringing"

How would that be?

Suppose every Tom, Dick and Harry is making widgets that weight 8-10 lbs, because that is how they have always been made.

Some bright boy figures out that 7.8-8.5 is MUCH better and gets a valid patent.

This does not stop people from making the old 8-10 lb widgets because they overlap. Even if an individual widget was under 8.5 it would not infringe.

It would only prevent those trying to make widgets specifically in the lower range.

The patent's range of average MW is 4-8.6 kD. The FDA label states 4.7-11 kD.

Is the 4-8.6 range better? I neither know nor care. Copaxone is defined by what the FDA says it is. If TEVA had wished to submit some data stating that lower weight was better and get that approved, fine. But they did not. Instead they told the FDA they higher weight was fine,

If all they did was tweek the range a tad in order to gain a new patent, that is obvious.

Try looking at it this way. Does Copaxone infringe on the '847 patent? If yes, then you would have to explain how a third party could have come up with the same '847 patent a decade after Copaxone was on the market and claim infringement. If no, then a clone of Copaxone will not infringe. If you believe Copaxone was improved, then you need to ask why it no longer conforms to the FDA label.

I seriously doubt the CoM patents will both hold up and be deemed reading. One or the other, but not both.

The process patents are right up MNTA's alley, they will be able to non-infringe very easy, unless MNTA is a scam, in which case I will have to kill DD

On a lighter side, I believe the Indian courts have already rulled the patents invalid

P.S., agree that this really matters little. It's the FDA, stupid.

Will there be a pop on approval?

I would speculate right now that the price it hits just after approval is not that much higher than before approval and will be the high for at least 6 months.

Depending on how it plays I would consider any of:

. Cashing out a few days early
. Selling calls just out of the money
. Cashing out on the open (or even PM).

I do like the long term prospects, so would buy back in within a few months at the most.

This is not a stock that is going to triple on approval but there will be players thinking such.

No, this is actually a very slight negative.

This is a new burden on the defence. Previously it was sufficient to show intent to deceive and materiality (in the sense that the item weighed on the decision). Now it must be shown that the issue could have changed the decision. A higher bar for certain.

Regardless, for MNTA this has no effect. Between the trial timeline and the FDA, I doubt anybody is assigning any value to mC revenue over the next 2 years.

MNTA will just keep drifting up every Q based on the lack of mL. Other than that, the best PPS driver is back on the FoB front (or a 118 miracle).

Nobody here will have a clue how the OS numbers will change over 6 months.

Once the curves are published then some guesses could be made. Until then, all one could assume are proportional hazard curves, but the PFS data seams to look otherwise.

Wait till after ASCO, and then ask Clark.

Doesn't mean anything. That's why I chose it. But I think there is a similar sounding oncology drug out there, so FDA would probably object.

"Cioterra" sounds like "Goodbye World" to me, probably not a good name for a drug!

[Yes, I know there is an a in ciao, but I have enough trouble with English]

9 weeks in OS is fine and I just hope it holds. If so, the P value would only drop a point or 2 I think.

On the question of will ODAC care aout the IRR data, the answer is no.

The reason is simple, it can biased as they often know who is on which arm. The central review can not be biased, as they are truly blinded.

As to the root cause, I have no clue.

Agreed as far as it goes.

This is slightly less than half the events, so the P value would be certainly expected to drop. It will years till we see that though.

The main point now is that the trend looks good (though it would be nice to see the curve, we must wait).

We all agree that this is not a formal stat checkpoint for FDA, but a subjective factor on "is it a clinical benefit". At 9 weeks I will take the number (and I assume Merck thought the same).

Can somebody point me to the IP that protects the Coca Cola manufacturing process?

Re: AF and biocrap:

In terms of picking a winner, AF is no more than average. But for picking losers, I think his hate mail list is likely 90% or so.

Re: nutcases

You are dead wrong on this.

There are not hundreds, there are 10s of thousands (the number would be much larger but must of this crowd does not invest in stocks).

Seriously, people follow this garbage all the time. How many people believe the US never landed men on the moon?

And I am not even getting into the religious nutcases.

Re: RKRW's "Here's a good primer on ALK." link.

Per the front page of the grace website, they are down for a rebuild until Sunday evening.

VRTX quiz:

"Note 3: On January 1, 2011, the Company began capitalizing its inventory for INCIVEK (telaprevir). "

W/o commercialization it goes as an R/D expense.

Re: Pantginis

This guy is either a complete fool, or else just spits out any BS he needs to make his real customers happy.

He was hyping INGN when everybody knew it had deteriorated into a semi scam (it previously had a real candidate in Advexan, but when that failed they tried to pretend otherwise with some BS subset that made no sense, and he supported them).

http://www.investorvillage.com/smbd.asp?mb=1366&mn=1502&pt=msg&mid=1509482

Re : ARRY

I have come to the camp that unless one is damn certain there is a price driver in the near/mid future, it is just better to do the financing and take ones lumps.

The problem is that if the stock goes drifting as you wait, the "short the financing" crowd will pile in.

It is not just producing the biosimilar, it is also proving that it is such.

DD: Yes

Zipjet: Sell puts

Me: Told you to buy months ago, WTF did you not listen

To be honest, DD and all have provided a ton of superb information for you. Now it is in your court.

I like keeping it (mL) under about 55% or so, but I suspect that SNY is so happy to see the revenue stream they are getting that they would not launch until under about 35%.

This is likely a new situation for all, and nobody will be that quick to screw up.

And I think we need to ignore the recent blip if as [I forget his name] is correct that SNY is having supply issues. Obviously a supply constraint would not cause SNY to launch.

Re: A Sanofi authorized generic.

There is good reason to believe that SNY will not launch as long as the branded Lovenox holds a decent market share.

An AG will hurt MNTA, but it will also hurt SNY. The only thing that would change this dynamic would be if Lovenox's market share dropped significantly.

One can try to modle this all they want, but the easier way to see this is the simple fact that Lovenox continues to bring in a good bit of gross profit despite having a generic challenge. Why would SNY upset the apple cart.

I suspect there are more retail investors who think QE2 is a cruise ship than those who know it is a monetary policy.

There is an elephant in the china shop, but he is asleep for a few years.