Received email reply from Dr. Stoll
I sent an e-mail to Dr. Stoll asking for information on FDA reply to cortex within 60 days. While he could not provide specific information he advised that FDA is back logged and has comunicated that they will reply but could not adhere to the 60 days as previously outlined. To me this is good news, I realize that this has previously been posted but since I recieved a personal reply from Dr. Stoll and we are on hot cools here, I thought I share his words. Here you go:
I can not provide information to you which has not been provided publicly. However, I can tell you that we have checked several times as to the progress of the review of our submissions to the Neurology Division at the FDA. They have been responsive, but have not finished their reviews of our documents. Apparently the same personnel that is reviewing our document is also under the gun to meet several PDUFA deadlines for other drugs under review and simply have not had the time to complete our review. There is no specific deadline which they have to meet because the FDA lifted the clinical hold last October, but simply placed a human dose limit on CX717. To get them to change the limit does not trigger a specific deadline. We have specifically requested to raise the limits, and as long as the agency has been getting back and telling us that they are working on it and do plan to respond (but they can not avoid missing the timeline estimates they gave us earlier) our hands are tied. We have no indication what-so-ever on how they are reacting to the material submitted. We still remain confident that we have made a solid case for elevation of the dose for CX717 and hope that in the not too distant future we will get some response.
Roger
Roger G. Stoll, Ph.D
President Chairman and Chief Executive Officer
Cortex Pharmaceuticals, Inc
15231 Barranca Parkway
Irvine, CA 92618
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