News Focus
News Focus
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gfp927z

06/25/07 5:03 PM

#6900 RE: BaalZebub #6899

Baal, Just curious when you received that email? Thanks.
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upndown1313

06/25/07 6:14 PM

#6901 RE: BaalZebub #6899

So yes they did respond within 60-days, and the response is we need more time. This was predictable. It could be a long summer. Since this is not part of a filing, this will get low priority. It may make sense just to file the IND to start the trials just so they can get in the queue pending the decision.
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ampakineman

06/25/07 9:59 PM

#6903 RE: BaalZebub #6899

It's ironic. We may have gotten a quicker reply if a total HOLD was 'on' rather than just a dosage restriction.

After two weeks of agonizingly awaiting a response, we can now look forward to a long hot summer, without an inkling of when we'll get word from the FDA. It's another way of putting the squeeze on small companies.

If this 'news' is indeed genuine, and I believe it is, then our share price will probably take a good hit over the next few days.......Ahhhhhhhhh, the life of a CORTEX investor. If it isn't one thing, then it's another!

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neuroinv

06/26/07 12:06 AM

#6907 RE: BaalZebub #6899

Reading between the lines--if the FDA was on the verge, this would read differently. They have not yet reviewed 'all the documents', which puts the time of decision-making and signing off by the necessary parties farther off as well. Personally, I'm am revising my expectations to 2nd week of July. I don't see anything in this that bodes negatively for the decision--just the timing.

And we would not have been better off if this was a formal clinical hold.

NeuroInvestment