Money4, Here's a repost of Dr. Stoll's reply to Ombow's email question (originally posted Nov 23) -
>>> 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
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His reply:
John, First, suggest you and other shareholders listen in on the presentation at the Bank of Montreal meeting in NYC on December 5, 2007 (we are on at 9 AM EST). However, I have already answered your question regarding the Psychiatric Division decision on CX717 for ADHD. While we will pursue avenues to determine if we can get a meeting with experts to discuss CX717 with that division, we are moving forward with the development of CX717 in acute respiratory depression. We do not believe that there is a high likelihood of any reversal of the Psychiatry Division decision for this compound. We obviously do not agree with the decision, but I would not count on having the decision reversed. We have plenty of other irons in the fire, and while we will continue to pursue a meeting with Psychiatry, in no way do we want our shareholders hanging on to that issue as an opportunity. Respiratory depression is very real and has a very strong mechanistic relationship among various species and we believe will have great likelihood of succeeding in humans as well. Also, we have potential back-up candidates which we will be pushing forward in ADHD because we already know that we can get a response in patients from our CX717 experience. Our objective is to develop a back-up which can succeed in ADHD. Also, we will continue to pursue Alzheimer’s disease which is also a promising area of therapy. We do not think that we will have to worry about our stock price being at this very low level later next year because we have several opportunities to show good progress with the AMPAKINE® technology and believe we can therefore improve our stock price. Roger <<<
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