Good entry point for September FDA decision Print E-mail
By Patrick Crutcher   
Friday, 20 August 2010 07:42

Having liquidity in this market is always a smart move, since some opportunities come and go, leaving only a window of opportunity to get a good entry price. After yesterday's trading session, the price action in Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) has opened a nice entry point for those who may have missed out back in March or April.

QCOR is currently awaiting FDA decision on its’ H.P. Acthar gel for infantile spasms with a PDUFA date of September 11th, 2010. This date came after the FDA extended the PDUFA date in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor. Back on May 6th, QCOR garned a positive vote of approval on safety and efficacy from the Advisory Committee for Peripheral and Central Nervous System Drugs.

In particular, “the Committee voted 22 to 1 that the Company has provided substantial evidence of effectiveness for H.P. Acthar Gel as a treatment for patients with IS and voted 16 to 7 that the Company has submitted evidence to support its view that a two-week course of treatment with H.P. Acthar Gel followed by a two-week tapering regimen provides sustained effectiveness. The Committee also voted 12 to 10 (with one abstention) that the Company has not provided evidence that adverse effects caused by H.P. Acthar Gel are manageable and reversible. In addition, the Advisory Committee voted 20 to 1 (with two abstentions) that the Company has submitted sufficient evidence of the safety of H.P. Acthar Gel at an effective dosing regimen.”

All that aside, we feel the risk of a non-approval has been mitigated by the fact this is their 3rd attempt at approval. Questcor initially submitted its supplemental New Drug Application for H.P. Acthar Gel to the FDA in June 2006 and was issued a "non-approvable" letter" by the regulatory agency in May 2007. It’s sNDA was resubmitted for H.P. Acthar Gel in December 2008 and completed its filing in March 2009. In May 2009, the FDA requested the company to include additional statistical analysis relating to data from one secondary study. By now, QCOR should have the story right on Acthar, given everything it has gone through.

QCOR has adequate cash and recurring revenues to push Acthar in the market further. This approval will help to cushion their bottom line even more and fund future research directions. They are are also exploring possible funding opportunities for exploratory studies in additional therapeutic areas having high unmet need that can use H.P. Acthar Gel. Now, that we are back in the 9.90-10 range, there is still some upside going into the FDA decision on September 11th.

 

Disclosure: No Positions




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