At wells fargo, very bullish statements on pipeline and that manta has built up a huge inventory ready for immediate release upon copaxone approval as FDA was rejecting desperate attempts by teva to delay with stall tactics and tainted studies. ((((((BUYING WITH BOTH FISTS))))). Laughing at shorts who argue risk here at $11 when MNTA already took a 50% haircut on old issues they continue to bring up in a feeble attempt to cast doubt on the future of MNTA which has multiple catalysts going forward
Sentiment: Strong Buy
why are you giving out false information, you wart ! UPGRADES not downgrades. LIAR LIAR PANTS ON FIRE!!!
Sentiment: Strong Buy
Court decided in mnta's favor and teva is on its hands and knees hoping for a long shot US Supreme Court reversal of that appellate decision, nevertheless MNTA has built up a huge inventory ready to release generic copaxone this month
Not so fast.
The judge rejected Momenta/Sandoz and Mylan/Natco’s claims that the COPAXONE® patents are invalid and unenforceable and found that the purported generic versions of COPAXONE® for which Momenta/Sandoz and Mylan/Natco seek Food and Drug Administration (FDA) approval infringe those patents. This ruling should prevent the FDA from approving, and the defendants from selling their purported generic versions of COPAXONE® in the U.S. until the Orange Book patents expire on May 24, 2014. As a result of this ruling, Teva also believes that the defendants will be enjoined from selling their products until the process patent expires on September 1, 2015. Furthermore, any purported generic version of COPAXONE® would need to obtain FDA approval prior to being made available to the public. At this point, it is unclear what the requirements would be for approval of a purported generic synthetic peptide.
While it must respond within 180 days, the FDA does not have to respond to a citizen petition before it rules on a related ANDA. 7 The FDA’s policy is to assess a citizen petition prior to approving a related ANDA, but the agency does not always issue its formal response to the petition before ruling on the ANDA.
No FDA approval equates to bad future. 7-8 points downside with no FDA approval equity issuance and expanded expenses for other non FDA able Baxter programs, 10 point upside (immediate) for FDA approval, then the skys the limit( even if they wait till copaxone patent expirations in Sept 2015) as they have then proved their characterization tech will produce viable biosimilar commercial products. that's my take.GLTA
Wow - you think the government cares how much the taxpayers lose. The CP has to be thoroughly vetted given it is the first in the new biosimilar gene game. Thus it will be months before any approval which will go to Momenta for an at risk launch for the exclusivity period.
Management thinks this will give clearer view of their potential, which it might then lead to a better response for any secondary offering IMO Supreme court review in October might be small catalyst.. If their science is so good and through can shareholders expect a minimum of six years FDA review of any future ANDA's?
they can try, -i agree with erporgene - the fat lady is singing -waiting on approval. I bought MNTA shares as I think it's possible there will only be one version of generic approved, and that I bet is MNTA. If I remember correctly, MNTA has an in with the FDA- The FDA has turned to it in the past for assistance. It should be interesting to see how this whole thing plays out.. I'm betting on MNTA....GLTA
Hilarious - a company that makes its living on generics trying to fight against competition for one of its own drugs - what it will get is a taste of its own medicine, so to speak.....a citizens petition -what's next? how bout a bunch of naked ladies standing in front of the FDA with signs saying "naked female genetalia against generic copaxone".....
No way- with the new CP just filed it will be months for all parties to put their input together for the FDA to say it gave everyone reasonable consideration.
TEVA makes 9million dollars a day from this product. One would expect their legal team to at least try to earn their keep.A one month delay from generic competition would pay a few salaries,bonuses,and
stock option grants to senior management-hey we all know they deserve it. Yes even when the stock price plummets these guy's will probably get a raise.
Wrong CP has ZERO impact on approval US taxpayers are losing tens of millions every delay due to this frivolous actions of TEVA and the stall tactics
weeks or months to wait - not a big deal. I'll be happy if it happens before EOY. Still plenty of money to be made by/on MNTA. ...
New gene expression to sway FDA and public sentiment? Will it work?-seams to keep FDA approval at bay for now
Will the generic companies finally be forced to do long time trials. Looking like it might be so.