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Re: neuroinv post# 14575

Sunday, 12/16/2007 7:18:06 PM

Sunday, December 16, 2007 7:18:06 PM

Post# of 50849
Neuro or anyone else with thoughts on this

It seems to me that there are 3 cases (leaving aside the worst case: no efficacy in RD, no change in PET signals):

1. Low-impacts rescue respiration without impacting analgesia, but are approved for acute use only.

2. Low-impacts are approved for acute and chronic use.

3. High impacts are approved for (disease-altering) chronic use.

Is cor viable if acute use indications with low impacts are the only ones they get through?

How about if they are limited to low-impacts only, but for both short- and long-term use?

If 2. and 3. are both true, this whole discussion is moot, because longs will make money.

My sense is that based on what is already known about the low-impacts, if they are effective in treating RD, their approval for the next round of trials is less problematic (acute indication, life-threatening, no alternatives, etc.,...). The clinical results will be available by May, the regulatory decision by end of summer (?).

When will we know if low-impacts have a chance as a chronically administered drug? The uncertainty about whether to go with CX-701 or a newer drug makes this a bit less clear, but taking management at its word, toxicology should be complete by summer (701) or late fall 2008 (new compound). This suggests that the earliest next date for a partnerable clinical trial using low-impacts for chronic use would be in early 2009. Does this sound reasonable?

Finally, when will we have a better sense of how well humans tolerate the high impacts?

So I'm asking two questions:

what are the timelines to these decision points?

How viable is cor (or what might its valuation be) if we end up with:

a. Low impacts / acute use only
b. Low impacts / acute and chronic use
c. Low and high impacts / acute and chronic use

Thanks in advance to anyone with thoughts on these issues.




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