Friday, November 23, 2007 11:33:25 AM
Hi Dr. Stoll,
There is quite a bit of confusion amongst shareholders concerning the following issues, which I hope you will clear up:
Are you still expecting a written response from the FDA detailing their reasons for rejecting the IND for CX717 for the treatment of ADHD? Apparently, according to the ombudsman at the FDA, they are no longer required to send you a letter because you inactivated the application.
Secondly, by inactivating the application instead of withdrawing it, did you leave the door open for further communications/negotiations with Psychiatry concerning the IND? Is there a difference between inactivating and withdrawing the application?
Thirdly, do you see any chance that Psychiatry might reverse their decision based on consultations between the FDA and Cortex and the consultants you hired to help you with the IND? Do you expect to have any future conversations with Psychiatry concerning the IND? Did you have any conversations with Psychiatry before or after the rejection of the IND? Is the tox issue with CX717 of such a nature that Psychiatry could not be persuaded to change their minds? Why then did Neurology allow you to proceed with AD trials?
Thank you very much,
John Mackenzie
P.S. Some questions offered by another shareholder --
What did the FDA tell you regarding CX717 and their rejection of the IND? Why did you feel it was necessary to inactivate the IND? Why not wait for the process to play out and reveal the hard reasons for rejection?
P.P.S. Many shareholders feel that these matters were not adequately addressed during the conference appearances you made and conference call you had. Would you please clear up this whole situation of the IND and its rejection by the FDA as best you know?
Thanks again,
JM
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