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zzaatt

07/09/18 4:56 PM

#13449 RE: Straightshot #13436

my overall assessment as a long is basically OK
but nothing earth shattering...

"basically OK" is OK by me,
but I would rate it much higher. Look at it this way (from an investment
perspective), if CLI get's "just" an "OK" from the FDA, the
result is a multi-billion dollar market, a brand new disruptive (there's
that word again) medical modality, and PSTI explodes
upward. That's earth shattering! I do hope that the results
are REALLY good (beyond the basic requirement for approval),
because I hope that patients will get as much help as possible.

I think the FDA may find themselves in a conundrum
when the CLI data is finalized... the p value may not be
there signifying statistical significance

We'll have to see, but I'm very
encouraged by the IC results and the fact that it confirmed
their dosing strategy for CLI (that's what they said). Also, keep in mind
how devastating that disease is (and how little toxicity), and
that is part of the formula that will be used by the FDA.
I'm optimistic on the coming CLI results.