In short, yes, they vote at the end. But keep in mind that is merely the recommendation. The FDA does not have to follow it, but they usually do.
Certainly into the $40's on news of completion of the FDA file and over $50/share upon acceptance of the NDA by the FDA to proceed forward. This would accurately reflect the low end of value given these milestones have been achieved.
Remember, hedge fund managers can sell unlimited number of shares short, even shares that do not exist. This way the markets are always crooked & rigged. You can't buy unlimited shares, even those that don't exist, only sell them short.
Remember that GSK walked away from Drisapersen completely. Now we are hearing about very negative safety data that was covered up in the phase III trials. When that comes to light, it will be very hard for the FDA advisory committee to recommend approval.
This is an inconsequential event, though one of a hundred details they will need to address. More like going to the dentist to have a cavity filled. An annoyance to be sure, but not a threat to livelihood.
80% yes accepted for filing.
80% REJECTED at the AdCom vote due to lack of efficacy and safety problems. Especially considering Eteplirsen is directly following, so DMD patients have a much better, safer, more effective drug coming immediately.
For those who are skilled and disciplined investors.
Hey, we like buying stuff on sale at the store right? This is the same thing except our stock is on sale. PTCT is fine. It is just a broad sell off.
ISIS and the rest of the BioTech industry is getting hammered as part of standard market manipulation. Nothing wrong with the fundamentals of ISIS - everything is in tact. It will come right back.
An RTF doesn't hurt SRPT in any way, though it is unlikely. Much more likely is he FDA will file on the BMRN drug and it will get voted down in favor of a drug with higher efficacy and lower toxicity.
No tide has turned.
Nothing has changed.
All the optimists are still here, but our world doesn't revolve around this board the way some peoples does. We come by when it is convenient for us, nothing more.
Won't be good. That's for sure.
Since Yahoo does nothing to stop the haters and spammers, I find myself looking for a better stock message board. Any suggestions? This one is out of control.
Drisapersen does not. It really is that simple. While some would seek to mislead you by claiming EU/EMA rule of law would get in the way, it is because they know that Drisapersen doesn't work and Eteplirsen does work.
I wonder what the ramifications will be against GSK will be, and BMRN too, what else have they covered up?
There you go with those pesky facts again. What about the countless posts from the one spammer in his Mom's basement with 6-aliases?
They can't fight the data, they have no influence at the FDA and no control over the buying in the market, so they are pretty much helpless. All they can do is spam the board. They've got nothing!
Not at all, we simply don't care what you think.
We have the data, it's out there. Go find it for yourself. You are going to believe anything anybody else tells you so why should we bother.
You are irrelevant.
RTF would be extremely unlikely given the momentum BMRN has with the FDA. It would be an absolutely fantastic event for SRPT, but don't see it happening.
I would say 90% they will get NDA and 10% RTF purely off my gut instinct.