i think the fda's breakthrough designation is srpt; note the maufacturing comment
drug manufacturing could be the rating limiting step; well, we've had a lot of discussion on that and on several calls chris has focused on the maufacturing issues
i think srpt got the breakthrough desigation
thanks to previous poster for the reminder
FDA issues first breakthrough designation
Published on Wednesday, November 14, 2012
FDA has "recently" issued the first breakthrough drug designation, Janet Woodcock, director of the Center for Drug Evaluation and Research, said on Wednesday. She said the agency cannot disclose the sponsor or drug candidate. The breakthrough designation, created by the FDA Safety and Innovation Act, commits FDA to collaborate with a sponsor to accelerate product testing and development (see BioCentury, July 2).
"Drug manufacturing could be the rate limiting step" for implementing the breakthrough drug pathway, Woodcock said at a meeting sponsored by Friends of Cancer Research and the Brookings Institution's Engelberg Center for Health Care Reform. FDA will work with sponsors to improve the chances that manufacturing is scaled-up and approved at the time when breakthrough drugs are approved, she added
I like Acadia a lot but they would be more of an accelerated approval candidate rather than a breakthrough designation. Also, they released they're data the last week of November and the FDA already issued the breakthrough PR. I'm confused why it hasn't been made public yet and when it will be. I would imagine this would become public by end of month...? Also, the drop can often preclude good news as big boys catching light of this will try and steal shares by taking out stop losses. We may get word as early as next week in my opinion.
Finally, once this happens I expect a nice boost to occur in other small cap bios, for example HEB and ACAD, which have been beaten up a bit lately and and undervalued in my opinion.