The FDA would appreciate a press release from Sarepta if "Breakthrough Therapy" Awarded
Pharmacyclics announced yesterday (2-12-2013) that they received the Breakthrough Theraphy designation from the FDA for ibrutinib. They stated that the FDA is dedicated to using an "all hands on deck approach" to work on products that show promise in treating life-threatening diseases. Their partner is Janssen which is a partnership with J & J as the controlling partner.
Since the FDA is committing to make this effort, the pat on the back by Pharmacyclics was warranted. I suspect that Sarepta will be well advised to issue a press release if they are awarded ANY favorable treatment by the FDA and not wait for minutes of the meeting or some other humbug. The speech yesterday by Janet Woodcock of the FDA suggests that this would be a good week to for the FDA to award these expedited designations to companies where it is deserved.
This raises the stakes for an announcement this week from Sarepta, notwithstanding any favors they may owe their institutional shareholders.
Thanks to pinappleguava in the IV board for this information.
Shimp, the public doesn't know if Sarepta has even applied for the "Breakthrough Therapy" designation. All we know is that CG was going to look into whether the designation would be helpful before applying for it. Curiously, no one seems clear on what, exactly, the designation will mean. From the Pharmacyclics' press release: "Pharmacylics, together with Janssen, is working with the FDA to determine the implications of this Breakthrough Therapy Designation".
Srpt does not need breakthrough designations nor should they waste their time trying to attain it. What they need is to be on the market and available for patients who need their drug most. The fastest way off achieving this goal is via accelerated approval. Breakthrough designations is for early drugs looking for FDA advice on how to set up their trial and what endpoints need to be achieved. That ship has passed for srpt.
I worded it so they should announce AA as well as Breakthrough Therapy. After all, they have been on a "Fast Track" since December, 2007. At some point the fast track will begin to slow down if they don't show the attainment of some goal and thank the FDA for their kind attention.