so if you consider what the FDA said - lack of "sufficiency of objective sleep maintenance data"
and see that rozerem got approved with 2 objective sleep maintenance studies - and lunesta had 4 objective sleep maintenance studies - and both rozerem and lunesta only had one study of 44 days in length that was an objective study I think you can see that the FDA might want 2 objective sleep maintenance studies and at least one of these should be 44 days in length
THE KICKER - doesn't it seem strange that NBIX might submit the MR application without ANY objective sleep maintenance data for the 15 mg dose? - so they have one study now - so maybe that is enough or maybe they need one more short trial
but IMO i think what the FDA may be looking for is very simple - just a similar amount of objective sleep maintenance studies compared to other approved drugs - maybe NBIX doesn't want to look stupid and admit that they may not have submitted ANY objective sleep maintenance data at 15 mg - thus how could they expect MR could get approved - can you imagine what the market response could be if NBIX really only needs a 44 day or 2 week sleep maintenance study to get MR approved at 15mg - it seems that might be the case - and if so why are they killing the stock over refusing to just admit that they blew it on the original MR application - its my opinion that management really screwed that up - sooner or later they will have to face that - it seems pretty simple and obvious IMO
Great post, good thinking...I am in agreement...this is a great drug..and this company will be flying between $60-$90's in only a few months...I am grateful for the shares I was able to buy at these low prices...its like a 7-1 stock split...
that's bad business. I think they screwed up and are playing with the cards dealt to them. Can't imagine PFE killed a 1B drug with not having a 44 day study included and if that's all it will take and still walk away. Insiders would be buying like crazy if that's the deal. Too bad those trades are delayed in reporting. For longs sake, hope it's short and sweet and a fast rise.
I would like to believe that NBIX is a buy at these levels and that a short clinical trial would allow for approval, as I am eager to get in on this stock. The big problem I see is the fact that Pfizer dropped out. Pfizer wouldn't just up and leave if the problem were just a small fix. What does Pfizer know that we don't??
i did note that there have been ads in the local paper for particpants in a short term maintenance study. i called to see if i qualify and learned that they are looking for people over 18 years of age that wake in the middle of the night and have a difficulty falling back to sleep. this is a short term study that requires only 4 (not back to back) nights in the sleep lab. they wouldn't say who the company was, but the tested drug is experimental. i don't know of anything else in phase III at this time.
there are are few phase IIIs ongoing
go to clinicaltrials.gov
pfizer is on the hook for "phase IV" trials on indiplon (i put in quotes because it is not really post-marketing now), but probably there will be a financial settlement instead
it still amazes me how favorable the terms of the deal with pfizer were, and what they are still on the hook for
the fda has gotten more skittish and conservative lately across the board, so no one really knows what they will require. but analysts who say indiplon might never get to market are just wrong..the question is really when (see motley fool article today)
investors and analysts aren't really dissecting the data and prior precedent (at least in public domai - privately I'm sure they are), and that is why individual investors doing their dd can beat the market, as in this case when the sell-off assumes a worst case scenario which is imo an impossibility (i.e. never make it to market or tremendous delay with runnign out of cash before regulatory filing)
pfizer must have seen data it liked when it chose indiplon overlunesta, and same with current suitors (and management did confirm being courted for partnership in cc yesterday, jsut a matter of waiting for meeting with fda to determine regulatory path and ultimately specifics of an impending partnership for commercialization)
pinvestment, very good post, reality is always a kick in the face, but it provides for better investment decisions down the road. NBIX is a buy at this price level for the risk tolerent investor. I always buy in stages. (3 buys)to get to my full position in any given stock. let the buying start
**its my opinion that management really screwed that up**
I agree. Although with a remark that PFE was the one in charge at that time. So if they say that they screwed this up that would imply that PFE did the screwing. Since they are to remain in good relations theykeep this silent.
This unpleasantry will correct itself with FDA's verdict.
"Although with a remark that PFE was the one in charge at that time."
...and who has said that PFE was in charge of the submission process? It's hard to argue with PFE's experience that they would force the FDA's hand for a quick NDA decision. I sense that NBIX management simply didn't know what it was doing. IMCL redux.
What bothers me the most is that management is still not coming clean about the specifics of what the FDA is concerned about. It's obvious that they are waiting until the FDA meeting to give us the bad news, and at the same time tell us about their plan to correct it.
A bit clandestine and suspicious, to say the least. Until they come clean, this stock will face downside pressure.