So, we should ignore the companies update to clinicaltrials.gov where they reconfirmed July for the start of ESSENCE recruitment? Ones thesis adapts as the facts on the ground evolve. The company was under no obligation to update that site yesterday, yet they chose to do so. Personally, I update my thesis each and every time new FACTUAL information arrives.
You are free to believe that Sarepta was only trying to mislead and deceive the public by confirming the July timeframe yesterday when in fact they intend to delay the start of ESSENCE. Until proven otherwise however, I'm going take Sarepta at their word. ESSENCE begins recruitment in July. The company could wait until Monday to PR the ESSENCE start as I believe they have a bit of leeway on when they are required to inform the public.
Dunno. The company could have easily updated the clinical trials site if in fact they now believe that they will not begin recruitment until August. Instead, they chose to update the clincial trials site by actually standing pat on their July time frame. They did so six weeks after their last update. There was no need to update, yet the company chose to do so. For them to suggest that they expect recruitment to begin in July when in fact, they know otherwise would be deceitful, and counterproductive for Sarepta.
Yesterdays update was not done because Sarepta was obligated to provide a CT update. They chose to update their pages, and reaffirm July as their intended start period. Today may in fact come and go in silence, but that won't change the fact that the company yesterday reaffirmed their belief that ESSENCE will begin recruiting this month.
So Simp, the trial site was specifically updated today, more or less confirming that the company still sees July as when ESSENCE will start. Does that make you any more certain that the wait is nearing an end? With only 3 days left in the month, they reaffirmed that ESSENCE will start within three days.
I think you are correct, however, and more importantly, the start which was listed as 2016-07 was left unchanged today and presumably would have been updated if they did not intend on initiating ESSENCE sometime in the next three days. Clearly they would be aware of the need to extend the start date by now, if in fact that was required. The fact that they chose to leave that field alone, while updating that the trial is not yet recruiting,is verification that Sarepta believes the ESSENCE start is imminent.
More importantly, specifically what was changed is the start date that was listed which was "2016-06-16" was specifically changed to "2016-27-16", which uh, happens to be today.
Yo Thi, did you know that the company apparently had named their antiviral "Radavirsen" as far back as 2012? I didn't , but that is in fact the case. No big deal either way, but interesting.
It's NOT ok, to provide guidance and then absolutely fail to do that which you guided you would do. Lawyers can say what they want, but that doesn't make their statements correct. Sarepta is playing with fire by shunning their fiduciary obligations to their shareholders, whether they can invent an argument supporting their destructive actions or not.
Apparently, NOTHING moves this process. Not priority review, not fast track, not orhpan drug status, not months and months of additional time, not new data, not incredible 6 mwt stats after nearly five years on drug. The FDA seems to be paralyzed when it comes to forward progress with Sarepta/Eteplirsen. It just shouldn't be this hard. First drug to ever produce any dystrophin, and probably THE safest drug ever developed too. And yet, all the FDA can do is stall, and prevent those in need from finally having access to a drug that helps. No wonder Congress is wondering "what the hell is going on over at the FDA?".
Irresponsible, and destructive behavior from Sarepta if they guide "ESSENCE starts in July" , never update that guidance, and then absolutely miss July without ever saying a word. I see no valid reason for management to abuse their shareholders in such a manner. If that's the case, why should anyone ever believe a word that management states? They've had ample opportunities to update their guidance, and have steadfastly maintained
And of course, what has the FDA's response been? Further , needless wasting of time. They appear committed to doing the OPPOSITE of what Congress intended when they made FDASIA the law. The fact that we sit here, more than two months after several FDA initiated delays with no decision is reprehensible. The FDA has bungled DMD from the beginning, and the FDA sponsored carnage goes on.
Yahoo is doing everything in their power to make the stock message boards worthless. Allowing idiots to clutter every page instead of being able to ignore the garbage is just the latest method they've used to degrade the boards. If the rest of YAHOO is managed as poorly, the new buyer is in real trouble.
MIke, you should read more, post less. It's getting ridiculous. You're adding nothing but flotsam and there's already more than enough of that.