Ok, let's watch all the day trader shorts and holywallst and johnkeeleezz and tradingexpert4me dumpers pile in with their garbage replies to this post, but I'd like to just get the honest opinions of the good people who might visit this board what they think the chances SRPT has of getting AA from the FDA for eteplirsen, on a scale of 1 to 10, with 1 being not a chance, and 10 being guaranteed approval.
As for me, I give it an 8.
How about all of you?
Sentiment: Strong Buy
I give it a 7, but since I have nothing to do with the pharma industry - it doesn't mean much of anything.
It wld be good to get the opinion of someone who has actually dealt with the FDA.
Also, I wonder if any pharma executives from other companies have any shares in SRPT, and if so, how big a stake. That wld probably say more than any poll...
Finally, for what it's worth, I don't think the share price does much of anything till March.
For one, I don't see the company entering into any licensing deal with another pharma until they get the approval. They will be in a much stornger position to negotiate favorable terms after the approval than before the approval.
And since they announced the results of the 12 week test in December, the earliest they can announce the next test results is March.
Opinions to the contrary welcome...
It's a 10 - slam dunk. The dystrophin and safety results alone are sufficient for accelerated approval - the 6MWT results, anecdotal testimony from the parents on how the boys in the trial are flourishing and the political pressure brought by the DMD community will seal the deal. What do they need a licensing deal for - they have the money to get this through the clinic and bring it to market - why share the spoils with another company?
The sample size as a percent of the occurrence of this rare disease is not small. An example on the other side of occurrence, might be Hep C. A phase 3 might be a couple of thousand patients. That would be the entire population of exon51, DMD, in the USA.
Keep all the numbers in their approprite context. A small number for one disease, could be more than adequate for another.......JMHO
Sentiment: Strong Buy