They have met with the FDA but do no tell you what happened.
Not much new info in this press release.
They are getting ready to communicate the negative news about their meeting with the FDA.
Modified intent to treat is not an FDA concept but has been invented by SRPT management to make the data look good.
See you all on the way down when the bad news come out that the FDA wants real double blind randomized data to see if this drug does anything.
Wow how stupid are you? Been doing this for 25 years and you never think you can come across a dumber poster on the Y boards, but sir/madam, you have proved me wrong. Mark this post: All the debate centers around arguments about the data which gets twisted by the shorts and embellished by the longs. You all miss the point. This WILL be political. The drug works with no adverse side effects and that is a FACT as we have seen it with Max, how long it will extend the life of these children no one knows. I will tell you this (and mark this down and I will admit if I'm wrong) If the FDA denies AA, they will be committing political suicide and Jenn McNary and the parents of the other children with this horrible disease will make damn sure of that.
I totally agree Wallst55555,
it's anectodal, but have you noticed how chill/laid back the most vocal advocate, Jenn, has been since her meeting with head of FDA? All she'll say is that she's "confident".......................and, I'm inclined to be confident too, if she is. She'd be blazing a scorched path through DC if she wasn't reasonably sure that she'll be able to get the drug as promptly as possible for her other son. I would too. But she's been pretty low key since that meeting, and my guess is, with good reason.
It's good to hear a counter- point argument ( I'm always skeptical when I buy stocks- it keeps me from getting emotionally tied to them). That said, I don't think your thesis holds water. Bottom line: keep shorting and in the next 3 weeks, one of us either wins or loses. Pretty simple, although if there is no AA, I don't think it drops more than 20-25%, while the longer term upside could be triple digits. I'll take triple digits personally.....
Great idea. Put 100 kids on a sugar pill, just to validate what we already know. Lets watch them deteriorate in surrogate dystrophin levels, musculoskeletal and cardiorespiratory measures, maybe eventual premature mortality. Better yet, let's conduct this trial. Take a double barrle shotgun, put one empty shell in one barrel and a loaded one in the other. Then put it to your groin and pull both triggers. Tell us which barrel is most effective. That is the type of trial you believe the FDA will propose for these DMD kids.
I think you are missing the point. FDA is not the old FDA. IF the drug is safe and there is some hope in efficacy the FDA will approve based on Phase II alone. Please see this thread for more discussion on why FDA is not old FDA (Excuse the substance, but FDA's Temple wrapped this up with a ribbon for SRPT).
In the eteplirsen case there is more than hope as the results are outstanding. The trial is not randomized true but should SRPT mgmt waited for the patients in the control arm to die when they see clear benefit in the drug arm? Of course those kids will switch.
Sentiment: Strong Buy
Dude, you must be crazy or a short.......look at how the institutes are investing.....they have more brain power behind this than your entire family tree combined.....
Sentiment: Strong Buy
Sure. Did the institutionals also got you into Dendreon a couple of years ago?
Stock was $40 and is now $4.50.
Or how about Affymax? check their stock price today
Institutionals don't exist to help you make money. Financial analysts have never developed any drugs.