Won't matter much if a big guy steps in after Adcom or approval and partners or takes the whole shebang. PFE has been on the prowl, as have a few others.
LOL. That sounds like a Lifetime movie.
I'm sure many of the boys will be there with their families, and many moms of the boys will speak during the public's turn at the mike. No doubt it will heavily weigh on the opinions of the committee.
Also, a side note to gary. Please stick to reasonable expectations. You've been pumping the heck out of safety data and suggesting it will be released any day. You're giving ammo to schmucks like pearsby. So stop already. WE AREN'T GOING TO SEE SAFETY DATA DURING AN ONGOING TRIAL. We'll know it's safe at the Adcom, and then again at the interim review. (But we already know it's safe now.)
Um, no, and you know better. The trial isn't complete. Safety data won't be released to the public until it is complete. The FDA will be receiving this data on an ongoing basis. The public will likely get a glimpse of this data when the briefing documents for the Adcom are released. You already know this, pearsby. Please stick to creating reasonable doubts. This isn't one of them.
Brain cancer already has many treatments available that are specific to brain cancer. How many does DMD have? None. Big, very, very important difference. Eteplirsen is getting approved by February 26, pearsby.
Remember, you've got three trials that can provide etep safety data. Phase 3, non-ambulatory, early DMD boys. An additional 20 boys with safety data is being conservative.
I think it will be continuous. Ed has said that the company will continue submitting data to the FDA as it becomes available throughout the review.
By the time eteplirsen is approved, there will be a significant amount of safety data across dozens of boys. The FDA won't have egg on their face.
What dufus wrote that analysis? Does he/she really think an Adcom is going to say no when the FDA just approved a thoroughly unsafe, suspectly efficacious female viagra?
Why do so many investors play off Adam F as as bear? He's not and has never been. For awhile, he had issues with management and the rah-rah investors who thought CG could do no wrong, but he has always believed that eteplirsen works. (And he was right in his growing concern over CG's shortcomings.) Cramer has no control over whatever slant Adam gives. Adam has knocked plenty of stocks that Cramer absolutely loves, namely ISIS and BIIB.
Uh huh. You're really good at predictions:
"THEY will get a "missing info" letter and need to redo the whole trial"
Agree, kg. Big deal for the families. Absolutely no way an Adcom says no to getting eteplirsen to boys ASAP. It's about time.