FDA needs additional time for Questcor Pharmaceuticals' review Print E-mail
By Patrick Crutcher   
Thursday, 09 September 2010 04:02

Investors who may have missed the initial ride on QCOR's run up have been gifted another opportunistic entry point.

On Wednesday, Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) announced after-hours that the “FDA will require additional time beyond the current action date of September 11, 2010 to complete its review of Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS).” Additionally, QCOR and the FDA have been updating and modernizing the product label for Acthar, which has not been modified since 1978, when multiple sclerosis was added to the label, which is now complete.

QCOR was notified that the FDA needs some additional time to finalize the wording on the label, review the proposed medication guide, and define post-approval commitments, if any, for the IS indication.

We want to reiterate that we believe QCOR will receive approval. The risk of a non-approval has been mitigated by the fact that this is their 3rd attempt at approval and Acthar is a well-understood drug. They received an overwhelming 22-1 vote in favor of approval. There were some lingering questions about some of the adverse events seen in the trial, however, as the panelists noted the efficacy far outweighed the risks. Additionally, much of what was discussed in regards to safety, concerned labeling and how to mitigate some risk by having a clear and concise inserts to assist physicians.

Labeling can be cooperatively done between the FDA and QCOR. This is a patient population that needs effective solutions for this rare and serious disorder, which effects roughly 1 out of .

We see no reason for non-approval and QCOR has been actively working with the FDA, which is a very positive sign. Beyond this, QCOR is still a profitable company and will likely see a boost in earnings(5-10%) with approval. They also noted third quarter 2010 prescription and sales levels were encouraging. So for those still interested in QCOR, today’s news should be a gift.

Shares of the company closed Wednesday's session at 10.38 +0.76 (7.90%), but given the news after hours, the stock began to fall to $9.80 -0.58 (-5.59%)

You can find our initial report on QCOR at the link below:
http://biomedreports.com/articles/most-popular/51199-good-entry-point-for-september-fda-decision.html

 

Disclosure: No Positions




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