News Digested - Trading Has Flatlined - FDA on Horns of Dilemma
90 minutes is all it took for stop losses to be taken out, fear and greed to cause huge swings, shorts to cover and now more normal trading. Not much offered on the sell side in terms of block trades; just retail action from here on out. SRPT comes out the winner in this race. Will SRPT need to conduct a Ph 3 with the absence of safety / toxicity issues? Will the FDA make the parents of DMD boys wait another year for a life saving drug to be available? The FDA is on the horns of a dilemma.
There is no delemma They will approve this drug as soon as it is commercially available anybody with a clue can see that. Its SAFE and it works period. only Question is what to do with the other exons and that is why they want a 4th biopsy.
It worked for 11 boys, and while I'll be "thumbs-downed" for saying this.......a random sample takes at least 15. That's the only knock on SRPT at this point. Has the FDA ever made an exception with so small a sample size? How do they overcome this apparent issue? What's the precedent?
Don't paint me as negative; that would be false. I'm a pragmatist and a realist, that's all. How does the FDA reconcile the small sample size, and would they be creating a precedent that could bite them in the #$%$ later. That's why the FDA is on the horns of a dilemma; and they know it.