Um, if you've followed the long twitter history of Dr. Nick, you'd know he talks out of his ash. He has absolutely no clue regarding anything. Seriously. Everything he says should be disregarded.
I doubt it. My hunch is that Adam wrote the story on his own cognition. BECAUSE THAT'S WHAT JOURNALISTS DO. They write about hotly debated topics. Why is this hard to understand?
Probably. Not because it's a good drug, but because of strong advocacy from DMD groups. PPMD and a couple of other heavyweights are going to push hard for its approval.
It wouldn't be a new precedent. There were several Twitter posts the other day giving examples of failed Phase 3 drugs that made it to market, per an Adam F request. Heck, you could argue that the female viagra which was just approved failed its Phase 3. And the Northera Phase 3, while succeeding, was incredibly flawed. Both were approved for one reason: overwhelming advocacy report to treat conditions with no drugs available. I don't understand why SRPT investors are so adamant that drisa won't be approved. It probably will.
AF reports on sensitive subjects. That's what journalists do. All he did was present the bear view. He made no subjective statements about whether he agrees, and to the contrary, has repeatedly stated previously that he disagrees with it.
I, for one, like knowing what the bear thesis is, and frankly, any reasonable investor should. It's good to dissect it to decide if your investment still holds up. In my view, the bear thesis is flawed. Simply put, the FDA not only agreed to accept the NDA, but the final meeting that led to the NDA acceptance was touted as highly productive. Additionally, the small n is no longer going to apply. The FDA wanted more data. By the time Adcom rolls around, they'll have plenty of more data (and they already do). I don't think the FDA would have accepted the NDA if they planned on rejecting the drug. The FDA knows that the Adcom review is going to be overwhelmingly positive for recommending approval for eteplirsen. They aren't stupid, and in the face of that, there's no way they reject its approval. Add to this the fact that over 90% of new drugs are being approved, and I think it's a lock. The FDA wouldn't have filed the NDA if they planned to reject. Bears are effed.
I have to disagree. I think the trend still applies, in particular because DMD has no approved treatments. Although I think drisa probably shouldn't be approved, I believe it will, as well as eteplirsen.
Because God wants to punish you for being acting like a baby in a grown man's body.
Well, given the fact that Biomarin likely will be sold by then, you're probably correct; that is, if SRPT isn't sold too.
If China controlled the U.S. economy, we'd be down way, way more than we are now. This is all part of a normal correction. Look for an upturn right around when the Fed decides what it is doing with the rate hike in a couple of weeks. I think the market will respond positively either way, although if the rate is hiked, could make one more big dip before turning. (The financial sector is still the most paramount to the market, and it will benefit most from a rate hike.)
"I would imagine the Chinese Government will step in and not allow the same mistakes our SEC has made in market manipulation."
Haha. Too funny. Somehow I doubt Communism is less corrupt than democracy.
Launch will likely take a minimum of three months. So revenue likely wouldn't be seen until middle of 2015.