As a pathologist are as comfortable with a 'lesion' that appears at 2 weeks and continues to be seen in a static fashion(without any progression)at 13 weeks. This is not simple 2 and 13 weeks, but comparable to a few years of truly heroic dosaging at 50-100 times the daily dosage in man over two years time.
What kind of toxic scaring or toxicity of any type appears, and then doesn't progress? Do liver changes? Do nephrotic changes? Say there is a precancerous cluster of cells after giving nicotine smoke to rats at 2 weeks, might that not progress at 13 or 36 weeks. With the rat lifespan, one can make certain assumptions in man, so 2 and 13 weeks are greatlly extended in man.
What sort of toxic lesion is not found at all with frozen fixation? but seen in paraffin-based histological screening? I'm not a pathologist, but studied neuropathology as a hobby for years, and I've never heard of such a finding: lack of progression, lack of appearance with frozen sectioning, lack of any behavior changes: taken one by one, these findings might not account for that much, but taken together they suggest something other than a toxic finding. Having said all of this, nothing would surprise me with the FDA. I am a fan of conspiracy scams. I've seen them fu$% many a small(and large company), and don't trust them. But I'm convinced here that the weight of the evidence no longer suggest toxicity with CX717. I view the worst case scenario here that the FDA might ask for a 6 month toxicology study or adding another species to duplicate their finding, which Cortex would have to comply with: that's the worst case; the best case, and Cortex gets dosing liberalization . . . this is just a matter of when it occurs. Keep in mind the following: real time lost, money lost doesn't account for much until CX701 moves into clinic in a year for phase IIa studies. Until then, Cortex and tweak what needs to be tweaked with CX717. CX701 will enter phase I trials around mid year, so it's not as if Cortex is wasting time at the expense of some other development. The stock price reflects total failure in almost all programs, and with this data being developed over the past months: the finding would appear to have a good chance of being artifact; that's more than we thought possible only a few months ago.
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