Why there are no strong arguments about approval or denial on this board? For new comers, who want to jump in before the PDUFA date do not see any help from longs or shorts on this board. Can some long help summarizing the history of filings and outcomes and why do they see that this should be approved this time? Someone out there in this stock for long please help?
Restless leg syndrome the #2 most searched on Yahoo today unreal!!! Maybe a sign of heart problems..
i understand fda can request anything they want..but in the last crl they mention that no human trials need to be conducted..and if fda was concerned about rats..if they wanted to, wouldnt they have asked for a trial the first time around..i think the company has established a safety margin of atleast 25..n epi studies were positive--which i think the FDA mostly wanted to see
In the case of Arena's rat cancer issues with the FDA, must be addressed as required in their CRL request back in December 2010. The company has yet to submit their studies data, therefore no 2nd CRL.
you can't assume FDA won't ask for a trial if they didn't the first time.
Also, you can't assume the company is telling you everything in the CRL.
BTW I am long this stock with put protection. So I am not just telling you stuff to put you down.
the company had a female carcinoma at 114 times exposure..in the past pfizer only conducted it at a max dose of 38x..this tells us that pfizer did not conduct these studies at extremely high doses.. also if fda wanted them to conduct tests in female rats.they would have told them either in the last CRL or during end of review meeting and the company would have done so..
There's another biotech Pharma facing the same issues with rat/cancer, Arena Pharma (ARNA) is also fighting the FDA currently and conducting studies to prove that their drug Lorcaserin does not cause cancer in rats.
Well, XNPT is the first company to show the tumor in female rats. Never had such a thing happened before so that FDA concluded that rats are not a good model for liver cancer risk. Now everything is changed. Actually XnPT ruined the chance of other similar drugs.
odds are 10% approval.
Major concern is the view of RSL.? Is it such a bad desease that a drug regardless of side effects warrants the risks.. If XNPT shows a good case that their drug carries zero risk, than i think we get approval. But last year the fact that their drug caused cancer in a rat scared off the FDA.. My gut says FDA will want to see a bigger and longer trial to make sure the drug is safe..
Best way to play it is buy the april 5 puts and the april 10 calls. If the drug is approved xnpt should hit 35-30, if it is denied will go down to cash levels which is 3 a share, so you win either way.. good luck.
Does the company offer studies or proof of some sort to dispell the belief that their drug causes Cancer in rats?
Just wondering that if this is the charge by the FDA, then what was done to prove otherwise?
Seeking alpha projects a $1-$2 price appreciation in case of approval because of the earlier presence of DEPO in the market for RLS.
Why, this board is than too optimistic about the price growth in case of approval? I see people stating it from $18-20 and as u said 30-35.
Sentiment in the market suggests a short sell whereas the price projections in case of approval scare to death to think of this strategy. Something is not clear.....
Also I do not play options, so my position will either a short or long.