We've all seen how long DEA has taken to finalize, longer than VVUS. Is there any scenario where Belviq can get pulled for any reason and never see market? It seems to be taking extra long, pardon the pun.
I am long ARNA and have become a little concerned over the length of time its taking to get this to market. Can anyone answer if the DEA had already finalized would it be public knowledge or will Jack surpirse us all on Monday and say hey we've been cleared we are ready for take off today?
dont want to burst your fantasy bubble but i am a long time reader of the board but new poster, ARNA long. Just had to ask these questions, no matter how naive they may sound, because its become very frustrating for investors and Arena doesnt really seem proactive in amongst all the negative tales from Adumb Fartstain et al.
1. VVUS did not go through a DEA process, they were not "new" drugs.
2. Earliest Beginning of March, latest April. I want to be optimistic about the CC being moved earlier, but I don't want to read too much into it. Why would they want to be up for a CC @ 0530 in the morning, why did it get bumped earlier (news?) I have been disappointed a few times being too optimistic, I'd like to see us close the week out strong in anticipation for Monday CC.
Sentiment: Strong Buy
I am expecting the DEA final ruling to be either Friday March 01, 2013 or Monday March 04, 2013 in a worst case scenario.
March 01, 2013 would be 42 day after the closing of the public comment period. and March 04, 2013 would be 45 days. 45 days has been the expectation all along; therefore, there is no need to worry about anything concerning the DEA. Lets hope that the DEA agree to make the final decision date and the effective date the same.
The Conference Call date of March 4th coincides well with the DEA final ruling date which could end up the Launch Date if the DEA waives the final 30 days. DEA's decision might come this Friday which would be sweet...
Sentiment: Strong Buy
Agreed, but why do you think it is being taken to the wire - March 4? They could've ruled for Jan 18 and made that the effective date also, Eisai made a pressing case for that in writing, which has not been addressed by DEA, Eisai or ARNA
Do you think the DEA would work in conjunction with Wall St. to ensure the shorts get their way out by doing just as you say pull FDA approval and open said exit door? Wow your thoughts do pose a troubling outcome for sure if said were to happen. I wonder how frequently the DEA has overruled the FDA. I can't find much on the net other than the recent legal marijuana that was overturned by the DEA.
The MJ thing is a one off as dea hate pot for many reasons like time and money spent the dea will leave IV class
I also think monday it will be all systems go why move cc to monday for bad news
just to many things lining up
I hope I am wrong of course but the goalposts seem to keep on shifting with Belviq. What happened to the fast track request that should have kicked in Jan 18 if granted? We have neither heard if it was granted or denied, tho if granted wouldnt it be on shelves yet?
There were articles stating that Doctors had been called by Eisai reps stating Belviq would be available in March which has shifted again.
The silence is concerning me. Jack has taken the highly unusual step of CC Monday morning before market which one could only really see as being a positive step, though devastating news from him would be Armageddon for the stock. Even if he fails to announce DEA finalization or a launch date that will probably be very bad for the stock price also I imagine as frustration will grow and we will be stuck in this channel or below as Wall St awaits launch and sales.