With the economy and biotech taking such a massive hit that is likely to continue for a a few more months before capitulation, buying here is still very risky. I personally wouldn't touch any biotechs right now, unless attempting to play for a short bounce.
What are you talking about? Crayons can be sharpened. I remember some of my crayon boxes even had a built in sharpener.
I've been playing biotechs since 2009, and I've never heard of such a thing. I suppose it's possible, but I think highly unusual and unlikely. The points will simply be debated at the Adcom.
Don't be ridiculous. Farkas is an idiot, but conspiracy theories like this are absurd. It is highly illegal for FDA staff to trade such stocks.
Well, I agree with your last sentence at least. I sort of think that if the company fails to get eteplirsen approved with this PDUFA, they'll have to sell out or partner for a pittance. They should have done one or the other long ago.
That's a very interesting idea, thig. You should run it by SRPT management. Seriously, that's an absolutely fantastic idea, assuming the company has actual documentation they can use to prove the children were turned away for that reason.
It was dishonest in the sense that they didn't share that number. I wouldn't call it a blatant lie, but rather an omission of the truth. Yes, they should have been more upfront. It made them look bad to investors, and more importantly, to the FDA. Sadly, this is something that happens with smid-cap biotechs all the time. Most BDs from these companies have glaring concerns that the companies were less than forthright about. That needs to change.
I think most longs have probably done these things and will continue to do so. But a reminder never hurts.
This was a live interview that occurred last week on January 19. Search Twitter for a link to the transcripts.
Not true. Brian Skorney of Baird still thinks there's a chance, and thus far, he has been the most accurate analyst in regards to DMD platforms.
That's not a placebo group. That's a control arm. A placebo group would be exon-51 boys who receive treatment of a saline solution without knowing beforehand that that is what they are receiving. That's what the FDA wants based on the BDs. And no, I don't agree with it at all. I think you don't do such a thing with a fatal disease like DMD. SRPT and the patient advocacy groups need to convince the FDA of this because they don't seem to get it.
Okay, looks like you are correct. The good news is that there is a strong likelihood that the program will continue. It appears Congress will make a decision soon. They've had a bill since March 2015 on making it permanent.
You're missing the point. You don't cancel 2 days on advance, especially when most advocates are already there. You wait another day to see how the forecast shapes up. You know, kind of like how public schools do it. How many of those in DC have canceled class on Friday? Eagerly awaiting your response.
NOT TRUE. The FDA will no longer be issuing vouchers come March. The ones already out there won't suddenly expire. The PRV is still good so long as etep gets approved.
My mistake. He was simply the voice of the FDA at the hearing. Word is that Woodcock will be (or at least was scheduled to be) at the eteplirsen hearing. If she is taking over the FDA role from Farkas, that would be a positive. But who knows.
No. Permanent committee members do not work at the FDA, per se. They are advisers. Farkas is an official working for the FDA. He may or may not be on the panel. He was for BMRN, so it reasons that he will be for SRPT.