FDA

No time for formalities, Acorda scraps FDA meeting in scramble to re-file CVT-301

Ron Cohen

With the clock ticking down to a final decision on key patents, one of its big investors agitating for change and facing a serious delay on its late-stage rescue plan, Acorda’s executive team isn’t wasting any time on unnecessary meetings.

The biotech filed a notice with the SEC today saying that based on its discussions with regulators, they can skip a Type A meeting and move to re-file their application for CVT-301 without taking time for any such formalities.

Just a month ago the FDA triggered a crisis at Acorda when regulators issued a refused-to-file letter on CVT-301. Acorda is looking at the loss of patent protection on Ampyra next summer, and without its cash cow the biotech desperately needs a major new product to fill the gap. So, instead of just continuing a high wire act, Acorda execs also have to scramble to get its application back to regulators ASAP.

Acorda couldn’t afford the initial delay at the FDA, and any misstep now could cost them even more dearly.

At the beginning of this month Acorda — helmed by Ron Cohen — also had to put in place a poison pill plan to keep Scopia Management at bay. Scopia has been pushing for a sale as it built up a bigger stake in the company.

Paul Matteis at Leerink is still not quite certain what Acorda has to do to get the FDA to accept its application, something the company never fully explained, but he finds the latest development encouraging.

While the press release highlights the ability of the company to re-file without the need of additional clinical data, questions on the initial reasons for the RTF remain outstanding and difficult to vet going forward. We had not changed our model on the RTF and still project potential approval later next year.


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