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... however i do think reverse engineering a biologic is more difficult since you can't just turn a dial and adjust process conditions but rather have tinker with cell lines
Was going to buy some MNTA, before its recent bump up; should I try to wait for a decrease, or just go ahead anyway.
What is the "decent market share"?
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 hope the Fed at least can broadcast something that will make all the scaredy cats not sell everything atthe end of June.
Re: Boeing
For commercial jets they are very well placed. The 787 really does up the technology and I would expect it do be dominate in that class over the next 2 decades.
On short range equipment I suspect they will not fare well. There are already decent players outside the big 2, and as somebody has posted on the BTV board China is cloning some regionals (including the MD-88 which is previous version of the 717).
The big question though is military. At some point the absurd US spending on this needs to be cut.
Anyone think the market goes parabolic into the end of June (ie end of QE2), because asset managers are going to squeeze as much alpha into their performance as possible as long as there's easy money around - thereby, getting all their "easy money" or "easy gains" in the first half, while the second half is more "unknown"?
I do not believe QE2 ends. They might not call it such, but the FED is buying way to many treasuries to get out of the game.
There are many ways that Geithner can use his magic ATM.
Any guess how much copy-cats or counterfeits, with good copies of labels and nearly nil FDA oversight from a few places such as China, South America, etc., would affect the generic or branded market?
Re: TEVA/MNTA dual settlement
IANAL, but...
I suggested this about 6 months ago and DD replied that he thought Justice (and maybe even Congress if need be) would throw a fit.
I am not that certain. For one, a Copaxone settlement on it's own is the type of deal the Courts have upheld. As a policy matter, I think this is wrong, but it is what it is. And this Congress is not going to act on this issue (last year might have been different).
The mL/tL suit on it's own would be much less significant (as there is another player in the market).
But does it make sense?
One argument for the mL/tL suit being settled is that it would avoid the possibility of having MNTA's patents being invalidated. So if TEVA really does not care about tL then they could take a modest payment to walk away.
The only reason for doing the deals together would be if both parties disagreed on price, but in ways that cancelled if you added them together.
Q on branded generics in emerging markets.
Is this really the same concept as it is here (or in the (EU, Japan, etc)?
I kind of have a suspicion that the driver for "branded" is that there is no real quality checks on the straight generics in these markets. So gaining the branded label is really more of a stamp of quality than any real product difference.
I am certain that many in Asia pay more for an Indian made generic than an unknown lower priced one (likely from China). Not a huge price difference by our standards, but real for some who live there.
SNY won't admit it but they had a shortage for all syringe doses especially the HD syringes because they were anticipating a TEVA entry that never came into fruition..
So all along TEVA has been secretly helping MNTA out by the BS "we will be approved next month" claims.
Is there any "stickyness" in this effect? Once the shortage is over will there be less of a gap between the product price/demand curves than there would have been w/o the shortage?
Might Sandoz need to raise prices a bit?
This was not an efficacy halt, and that is the whole problem.
The DSMB can request a halt when EITHER arm is doing bad for safety reasons. That is what happened.
The problem is that the efficacy data is now somewhat in question.
I do agree, this is not an FDA problem (unless one implies they need stronger controls on DSMBs).
"But there's not a hell of a lot you can do about it except to make yourself look unattractive" to a potential buyer.
Damn, I guess Bianco, Carter and the other biocrap CEO's are doing a great job after all.
Sorry BTH, if you don't know the difference between what makes a great CEO and what makes a great Scientist, I can't help you.. You have to understand the basics, sport..
So if something is a vaccine, in your sense of the word, but also can be used as a treatment, what is it?
Semi OT, but way to funny.
On the Y!MB for Radient (RPC) the number one board for 'also viewed by those who are here' was CTIC.
Could one build a 'bot that scans in all this and use it to auto-detect bio-crap?
MNTA/TEVA Re: Trial date
Even w/o the possibility of a PI there is still a reason why TEVA would want an earlier date if they were expecting approval tomorrow.
Namely the potential 2x damages. If TEVA was on the wrong side of this one, it could be a billion dollar legal game to let it slide.
It is pretty easy to see with her many other public staements over the years that she is "PRO" Teva.
Nothing that sinister; they’re simply opposed to government regulation on ideological grounds and don’t realize how screwed up things would be if the FDA got out of the efficacy business.
Disagree,
Somebody on the WSJ editorial board clearly has a personal issue with the FDA,
The WSJ came out and supported CTIC on PIX. They are off their rocker on this one.
EDIT : I do agree it is not sinister. Just retarded.
Re:
Do you think the stock is worth holding for Apaziquone, Zevalin and the rest of their pipe?
Re: SPPI odds on Fusilev label expansion
I will go with 25%.
L-leuocovorin almost certainly works as well as leuvovorin, but the FDA wants meat.
SPPI presumably tried the old trick of claiming that retaining 50% of the comparator drug’s treatment effect is all one needs to demonstrate non-inferiority, ...
SPPI...Re-Fusilev...The FDA requested additional data which the company expects to submit in the 3rd quarter of 2010. The FDA DID NOT REQUEST any additional efficacy studies.
I think he's simply uninformed about the Hatch-Waxman process. Maybe I'm being naïve.
"Feuerstein is evidently calling RPC longs Radient Retards. Insofar as I think RPC is a scam, I’m inclined to agree."
So what is Adam calling CTIC longs?
Bianco's bitches?
Re: MNTA Kramer and all
Whats up?
Markham?
We need corporate governance reform, badly.
Why can't they just dump a massive amount of liquid nitrogen on the thing?
What do you make of the fact that the FDA argument here rests solely on the lack of a good and stable raw material supplier - not one word in there about lack of "sameness" or failure to meet their 5 criteria?
MNTA: "Curious why the heparin must come from China?"
I suspect the harvesting of the pig intestine material is the issue. Even using illegal workers I doubt you can even come close to matching the labor cost.
China has both cheap labor and plenty of pigs.
Re: Sleazbag bio's playing the Japan nuke scare
I am truly stunned we have not heard from HEB on this. Not only does Ampligen cure everything, but their Japan pals love it.
I guess they are just to busy ramping up production to issue a PR.
Fukushima reactor- This guy does an excellent job of explaining what happened
OT: Our media and the Fukushima reactor.
On one if the major US news networks (sorry, forget which) had an expert on to talk about this subject a few days ago.
When it was mentioned that one of the reactors had an explosion due to hydrogen, the "expert" questioned that. He thought it might have been helium, a byproduct of nuclear reactions. He even went as far as suggesting a translation error.
This wasn't some telephone interview (where the network might have been "punked"), they actually had their "expert" on camera.
OT: RMBS(TEVA)
Shockingly, TEVA shut up, and TEVA had legal counsel at their very next investor presentation, cited by name and actually at the podium or part of the presentation. To which I commented, absent a company like RMBS, I had never before seen legal counsel garner such credit or play such a prime role in an investor presentation.
Peptimmune, who filed a Citizen Petition with the FDA vis-à-vis generic Copaxone,...
Agreed. What’s bizarre is that, to my knowledge, no one in a position to know for certain has asserted that Bydureon was in fact statsig inferior.
No, we cannot say that. Teva might be able to get a preliminary injunction to block the launch of generic Copaxone; however, the likelihood of Teva’s getting a PI will be diminished if the Judge believes Teva is unlikely to prevail in the Copaxone trial.
Re: GNTA share history
If you bought 15,000,000 shares of GNTA in 1997 and held your entire position to the present day, you would now be the proud
owner of 1 share.
MNTA: Re:
In zero sum games the weaker gets the short end. That would be MNTA.
What is PK? Thank you.