Make no mistake CG has done a brilliant job to date but the CC was a major misstep.
The messaging should have been along the lines of:
We are excited and pleased to announce that Sarepta has decided to submit an NDA for eteplirsen in the first half of 2014 based on our encouraging and positive discussions with FDA which focused on the strength and statistical significance of our surrogate and clinical data from the eteplirsen Phase IIb study and the acceptability of this data for an NDA filing.
While FDA has not yet decided whether dystrophin is a surrogate marker reasonably likely to predict clinical benefit, we note that FDA has multiple options for approving eteplirsen including on the basis of the 6MWT clinical endpoint.
Today marks what we truly believe is a major step forward for the DMD community as we seek to establish eteplirsen as the (first and ) best in class therapy for (exon-51 related) DMD etc....
In other words,the focus should have been on the certainty and confidence of your decision to file for an NDA rather than expound and expand on potential FDA issues that will, by definition, be uncertain at this point.
The Street's Adam F. already established that a nod from the FDA signaled a de facto approval for all intents and purposes. A very nice baseline to work from. The CC only served to call this into question and raise more questions and issues than answers--a feast for bears.
The CC should have been short and to the point. Instead, gold was spun into straw as certainty was transformed into uncertainty.
In this case, less would have been more...much more.
Sentiment: Strong Buy
Today was good news and had little to do with the CC. It had to do with shorts, who crushed it to try to get the price down. There was no change in any rationally expected timeline, no certainty that AA won't happen, no reason to doubt manufacturing is not coming along, no reason to doubt the drug. It was really nothing but a head fake orchestrated by the bear camp.
No big deal unless you interpreted the news correctly and bought in premarket.
All I know is that when I went on the road at 7:30 we were 10 up and I got home this evening and we were almost 9 down. The one catalyst event I missed in between the long work day was Chris speaking. Well that and losing an #$%$ of coin on paper. Wish he could spin like a neighbor hood organizer who would be king.
it started tanking long before Chris spoke... he made it worse, but it went as high as 68 dollars PM and then slowly started to tank down to about 43 prior to the call.... so i wudnt blame this all on him....it was investors misreading the PR and interpreting it as good news when it wasn't....
Sure, it is easy to spin the message precisely when you don't have to take questions or are not required by SEC rules to disclose all material information. Anyone listening to CG's calls over the past couple of years knows that he lays out all the facts and counts on some intelligence of the listener to discern what is real and what is subject to the realm of FDA interpretation, which he will not do for them. The fact that the FDA is not yet educated sufficiently on the nuances of dystrophin to make a formal validation as a surrogate, doesn't negate the real fact that Etep generates clinically meaningful levels of dystrophin in a consistent and safe manner. The real fact that the FDA has opened the door for SRPT to file for approval doesn't negate the fact that the FDA has significant latitude in how they handle that filing. Just because CG balks at speaking for the FDA or predicting how they will approach the review/approval process doesn't mean there are insurmountable issues. The fact that analysts and the weak-handed can't discern what is real and what is normal, everyday FDA uncertainty is a reflection on them, not CG.
tredleon..100% spot on..cg cannot control the everyday move of the stock..the move is no different than the move last October..stock hits a hi of 45 then spends the next few weeks retreating..this time an atm could and should have been used allowing the company to have over $300 mill in cash..let the dust settle and this stock goes back to new hi's over time..
Keep in mind many said the trial was too small for the FDA. They were wrong. Many then said the FDA would not allow a aa/Nda filing. They were wrong again. I believe most got it wrong today again. We will see soon enough.