As with the government, nothing is ever clear nor certain. I expect Janet will give them some kind of 1/2-baked approval that leaves everybody wondering what it means. Something like they can have approval for kids just until they can complete a bigger more definitive study, then the FDA will get another crack at it, so we will have to go through all the turmoil again.
For now, I hope and pray, for the kids sake, that the FDA finds some way to approve in some fashion.
You are too kind to say he was feeling anything at all. Seriously, who would seriously state that they want to see some young children die to prove (for the benefit of their career) that the drug works better and saves lives? That is an indefensible position.
If there were safety concerns that the drug did harm, then maybe - but absent that I just don't see it.
But who would initiate a buyout? Certainly not at any premium. Barely at the levels it is at now ($10/share). If I was buying I'd want some sort of assurance the FDA would conditionally approve Eteplirsen, otherwise I'd be wasting my money.
Many Biotechs took it on the chin when the corrupt FDA shot down an outstanding drug (Eteplirsen) from SRPT which provides effective and safe treatment for boys with DMD that would otherwise die. While there are arguments on both sides (safe & effective vs. tiny (only 12 patients) phase 3 trial study with no placebo control arm) it is a huge blow to the pharmas. IONS will recover. SRPT - may as well if the FDA grands conditional approval or some other compromise (though the FDA is not known for its compromise).
The FDA refuses independent thought, refuses to think for themselves, and DEMANDS that young boys die in a placebo controlled study to show that Eteplirsen works.
I guess if you graduate at the BOTTOM of your medical class, the only option is to go to work for the FDA.
Yes the vote did happen and the result was not good. CNBC's headline at 7:44pm was:
FDA panel says Sarepta drug not effective for Duchenne's
FDA is absolutely corrupt.
I have long ago sold my position in SRPT but still am a strong advocate because I believe the kids deserve it. I think the drug works and gives kids hope who otherwise have none.
Sadly, I think the FDA is corrupt and that is why I sold my shares.
Still, I believe in the drug and the company and continue to pray for the best.
The recent run-up was a complete setup by fund managers and Wall Street. The FDA never changed their mind about anything. Hopefully the run-up gave some of you the chance to get out. Otherwise, dump out now before the Adcom disapproves the drug completely. That will slam the door shut on SRPT (sadly) - while dooming needless children to die.
I believe Eteplirsen works. I believe it helps kids and saves lives.
I also believe that the FDA is absolutely corrupt and there is no hope for approval.
A bad situation no matter how you look at it.
My 25 years as a Computer Scientist has taught me to weed out the wanna-be companies from the real deal. This is a wanna be. Get out while you can. Get anything you can out of the stock while you can.
Wishful thinking. It is a part time company run by part time people. No dedication. This is a hobby company. Good idea but they can't get a product to market.
It is still down 50% from a year ago, so needs to double before most even break even.
If you made money in this stock then good for you, you are in the vast minority. They have no product on the market, no revenue, and in my opinion, no hope.