Approval of Questcor's Athcar Drawing Near

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 |  About: Mallinckrodt PLC (MNK)
by: Sheff Station

It seems that if the FDA is going to approve Athcar for Infantile Spasms that there is no better week than this upcoming one. The 39th annual Child Neurology Society meeting is scheduled to be held this week from October 13th-16th in Providence, R.I. This meeting recognizes and reviews new treatments and advancements for specialists who deal with children in the Neurology field. From previous conference calls hosted by Questcor (QCOR), the common theme was that many of their company executives hoped that the FDA would have approved their treatment for IS so that the new labeling change, information, and news of approval could be presented at this prestigious meeting.

During the last conference call update shortly after the PDUFA decision date for approval of Athcar had to be delayed, the company was direct with shareholders that this delay was due to the FDA. If the FDA had needed greater than 3 months, then the PDUFA date decision would have been changed as opposed to delayed. The hope of QCOR management was that a decision would have been made before their largest conference meeting on October 13th where they hoped to unveil Athcar. Being that the PDUFA date was not changed by the FDA, that leads management to believe that the FDA is working hard to tie all the loose ends with regards to updating the labeling for Athcar. This should be approved fairly soon as we are 1 month past the PDUFA date. The importance of hitting the targeted PDUFA dates are important for FDA reviewers as they track all of time sensitive reviews in their yearly report updates.

In the last conference call update to investors, management made note of the fact that the Questcor REMS strategy is a relatively simple one for the FDA. This involves a standard medication guide which is the most basic form of the REMS program. There is also not going to be a black box warning with the new label. The company discussed that they will still be able to market the drug to the current patient populations under this new label they obtain from the FDA. Investors focused on this key aspect as it was addressed as a potential concern on the investor conference call.

Company management also discussed that over the last 5 years the FDA has shifted to a new format for drugs and since the Athcar drug label has not changed in almost 4 decades ('70s) that it needed to be updated to today's standards.

Questcor stated that the label is currently under review with only one division, but had been reviewed by “ALL" divisions.

Investors should understand that patience has been a must with Questcor and approval for Athcar for IS. It seems that the right time for the company is drawing near. The company is profitable and hopes that this approval will further grow their market dominance in the IS field and allow them to directly call on a customer segment that, without approval, they would not be able to tap into. The next few weeks will be interesting as the pressure will be on for the FDA to make a decision soon as the shortage of approvals will not occur during the hectic month of October.

Disclosure: Author long QCOR