Wow, lot of nonsense getting posted. maybe this helps some people...
1) FDA doesn't snail mail NDA decisions. They email the designated contact person at the company their response with a scanned attachment and call at the same time to make sure email is received. They then overnight a hard copy.
2) FDA doesn't give companies 3 days to put out any release be it approval or CRL. They have no jurisdiction there. However, the FDA does post drug approvals on their own website one day after approval. That gives a company the first chance to publicize it the day approval is received. SEC does require filing by companies on material items and this is where CRL would fall under. And the rule of thumb is to release the CRL news the same day or next day on open.
3) Tydurban's speculation on partnership is total nonsense. There will be no partnership announced within a week. Just doesn't work that way. I've been involved with that process firsthand many times and it is a process. If they receive approval BIOD will circle back with all the interested players and revisit their current proposals. That will take at least a month. Probably more like 2-3 months.
4) Same division(endocrinology) at FDA is reviewing Vivus application and they have a PDUFA two days before BIOD. VVUS news will come out before BIOD. Even if FDA just delays VVUS NDA we will hear about that before BIOD news. My guess is BIOD gets the news on Saturday.
Final thought... I am long BIOD and expect it to receive approval...eventually. Maybe now, maybe later. India data was clearly an anamoly, but FDA endo head could be mad at his wife this week and takes it out on BIOD. That's just the way it is.
One more thought...why anyone would go naked short BIOD I have no idea...extremely bad risk/reward for shorting here.
Not true. In Biodel's case the FDA is changing protocol. They are sending the NDA response over to them in an overheated truck. When Biodel calls the FDA and asks them what the burnt paper said the FDA is going to tell Biodel they need to submit a new NDA to find out. Those FDA guys have a good sense of humor.
How does one stay in touch with you? I've not seen anyone make more sense. Would you mind if I shadow your thoughts. Of course, I would do my own DD on anything out there and might meet you at a conference someday? Thank you for your input, it's very respected.