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Tuesday, October 16, 2018 10:28:08 AM
Todays “news” is meaningless.
Allowing patient access, early, outside of the P3 in progress means that the FDA has significant confidence that 1) PLX-PAD is safe, 2) that there's enough of an indication of efficacy that it's worth giving it to very sick patients. THAT'S MEANINGFUL! Especially for patients who need help.
From an investment perspective, just one more positive indication of probable success in moving toward approval!
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