This was a neutral announcement.
The bad news is that the WRO doesn’t seem like the preferred regulatory interaction. Invex overestimated it’s chances of getting a verbal Type B meeting with the FDA, in the setting of COVID stretched resources and previous scientific advice.
The saving grace to this all, is that Invex is liaising with a different division of the FDA with completely different endpoints. The preference for one vs. two pivotal trials is still unseen and is anyone’s guess.
The hard numbers are this. 33 mill in the bank=cash backing of the share price of $0.40. If Invex gets 2 trials from the FDA, this may get very close to that net cash backing. If they land 1 pivotal trial, this will rocket. Mid June will be very interesting.
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