Amped from seeing Wicked, I scrolled through IV and found the Wells Fargo transcript (the usual h and tt and p and three w's before this: earningsimpact.com/Transcript/81729/SRPT/Sarepta-Therapeutics,-Inc----2013-Wells-Fargo
And it all clicked in. We've got great chemistry, great outcomes and a great future. This is new ground being tilled by the FDA, and they want to get it right. The final piece of evidence is the poor kid who broke his ankle and took some time off from the 6MWT. Oh, right: he's coming back, stronger than ever, with a compelling video confirming that he'd prefer to sprint, not walk. Ask the DMD community: this simply DOES NOT HAPPEN.
So here we wait. What's the parallel? A spaghetti western with the good (us) the bad (10 million skeptics) and the ugly (Bud, Kelly and other provocateurs? Flyers vs. Bruins? Al Qaida against Seal Team Six? Whatever. In the end, the only "team" that matters here is the kids.
Assessment: the two sides are hunkered down, no one is changing their position, and we're at 44 and change on skinny volume. Time to bring it on. My take: no way this happens before July 20 opex. But pick any day from there to the end of the month, and watch the FDA rightfully claim credit for carefully picking highly qualified poster boys for accelerated approval. Me, I'm tired of the bashing, the ad hominem attacks and the downright ugliness. When investments start to cloud humanitarian concerns for kids who have no options, it's time to find another game.
Have a great weekend, longs, and don't sweat the small stuff. It's all good, or at least it will be, soon.
Very nice post, thanks! Think about this quote from CG from the document:
"As we stated previously, based on that guidance if we do pursue accelerated approval, we want to meet with them hopefully by the end of the third quarter to discuss CMC. And what will need to be in the CMC section to be accepted for filing as well. And then we'll have better guidance on the timing of the potential NDA if the FDA's support of an accelerated approval filing."
CMC = Chemistry Manufacturing and Controls. So the meeting being scheduled for sometime in July is to address CMC, and based on the quote the decision on AA will be pretty clear before the CMC meeting. Chances are CG knows now that the FDA is ready to allow an AA application, and that's why they're scheduling a CMC meeting for this month without delay. The market is seeing this too, and hence the buying that we're seeing.
I haven't heard anything about the CMC meeting this month. It should be by the end of the 3rd quarter however. After this upcoming meeting to determine the feasibility of an AA application will they have the CMC meeting since that CMC meeting could be dramatically different depending on what is said at the first meeting. The CMC meeting isn't a catalyst for the stock like this first one is.