i think its real simple. these ppl hit everyone with medical terminology and nonsense. the main concern is, does the drug provide a benfit that outweighs the risk.
i think of it as a scale. on the benefit side you have weight loss, lowering blood pressure and lowering risk of diabetes all good stuff. and the other side right now you have long term use that might cause heart damage. before, there were cancerous tumors also on the negative side but ARNA convinced the board that the tumors would only grow in experimental mice. very awesome job by ARNA.
the problem is the heart concern. and if im not mistaken most of the ppl that opposed the vote were mostly cardologists in that 18-4 vote.
so right now, i think its all about ARNA proving/convincing that their drug isnt much of a heart problem risk. they did a good job disproving the cancerous tumors so.. . . not to say one way or another.
another problem of the drug is that ppl only lost like 10% of their bodyweight after a year and regained the weight once being taken off the drug. so you have a drug that can mess up your heart for good but you regain the weight if you stop taking it.
but not to sound too bullish and start believing my own crap, i was impressed in how well ARNA was prepared for that last board and that the issues plaguing the approval arent new and the folks at ARNA know about them and have a chance to address them seems like they can pull this one off. but you never know with these boards.
they could disagree with the preboard, or issue a letter saying they want more tests with the heart issue and tell em to come back in a few months causing the price to tumble like friday. its not a slamdunk. but it has a good chance of being approved. i mean 18-4? thats really good.
either way i like the drug and i believe in the ARNA management so im holding onto my stock. but you have to decide whether its worth the risk to hold onto the shares before the fda date, because either way its going to be a steep climb or a steep fall when that decision is made and you have to weigh the risks.
very good analysis. I just read the script from the conference 18-4 vote. Even most yes votes were stated on record as being hesitant. Everyone keeps bringing up heart valve affects. Question to veterans of pharms, is REMS post approval , pre, or can be either one? THANKS