SRPT can benefit in many ways from what happened to BMRN yesterday. First, they get a read from the FDA on what is important. Farkas saying Drisapersen would kill patients speaks volumes. SRPT has a perfect safety profile so that works well. The panel also tore apart Drisapersen's lack of efficacy, which again favors Eteplirsen with outstanding efficacy.
Lastly, the only ding left against SRPT was the small trial size, but with the much larger confirmatory trial going on now, and consistent data with e smaller, the last obstacle is removed.
Now that it has unfolded, the FDA did SRPT a great favor by separating the Adcoms. Drisapersen has failed all by itself and they can't pretend it was due to any influence or anything else.
There are two areas where Sarepta emerges from Tuesday's panel clearly a winner and with a big advantage over BioMarin. The first is eteplirsen's superior safety. Barring any surprises, eteplirsen is much safer and better tolerated than drisapersen. FDA's Farkas won't be telling advisory panel members that eteplirsen has the capacity to kill Duchenne patients.
Second, Sarepta now knows how the FDA and the advisory panel members feel, generally, about Duchenne drugs. Sarepta will learn a lot from BioMarin's experience Tuesday and adjusts its own eteplirsen presentation to navigate around the trouble spots. This is where being second is a huge win.
Eteplirsen will be approved.
The confirmatory trial size fixes the small N issue that faced BMRN at their Adcom. Regardless of whether there are 160 patients as noted at ClinicalTrialsGov or 100 in some of the news articles, it is still a much bigger number AND the results are consistent with the earlier trials.
Yes, but the problem is, their drug doesn't work and Eteplirsen does, so that stark difference in efficacy alone will be enough to refute any patent claims.
Clovis is cratering this morning based on problems in their clinical trial data that showed only 34% efficacy rate compared with a just approved drug with a 59% efficacy rate. If the FDA requires additional data from Clovis, then certainly it should flat-out reject Biomarin's flawed drug that has a far lower efficacy rate.
I'm just a doubting Thomas. I want to see it and won't believe it until I see it for myself. I haven't seen it and don't necessarily believe it exists.
OK, but where did you see "a copy"? Pull it down from the Internet? In the FDA's office? The only source I can find is this message board, and that makes me very suspicious. No matter how I google it, I can't find any copy or even any reference of it beyond this message board.
Has anybody else seen this mythical survey? No matter how I search the Internet, I only find mention of it in his posts.
True or false, the stock dropped 20% today.
Remember who did this to you. There will come a time when you (as a consumer) can elect to use, or not use, Express Scripts.
One who needs to be taught a lesson. Maybe HZNP can form a pharmaceutical alliance - with other companies - and all exclude ESRX.
Oh, OK, then I guess you won't defend yourself to ESRX or anybody else that knocks you back. I guess you'll be a witness for the defendant (ESRX) as you see no harm done.