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Posted On: 10/20/2020 11:47:46 AM
Post# of 145873
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In summary - everything still intact, still forward progress, all positive news, adjust your timeframe and the rewards are still there.
Question re: 42 days addition + an observation
Primary is still 28, we just added 42 days and another interim @ 293, does this imply the following?
a) 28 won't achieve the p = .005 stat sig by itself at interim
b) 42 will achieve p = .005 @ 293 - while not our primary endpoint, could be enough to cajole FDA into EUA
Otherwise, if (b) doesn't work, then I think we have to continue to full enroll and complete the trial at shoot for p = .05 on the primary alone which DSMC believes we will achieve per the PR ("continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint"
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I did email MM to find out if the FDA was involved at all during the interim analysis, if yes, then we can rest assure that (b) is likely per the FDA's guidance.
STOCK REACTION TODAY: We all know this is positive news, why is the stock flat? I posit the following:
1) Expectations were met - many of us thought there would be some sort of endpoint pivot (42 days addition, technically not an endpoint) or continuation of trial (occurred) - hence the stock was already trading around with this expected news baked into it. I.e. Nothing new today really, so stock is flat
2) Capital raise inevitability - I think this is the biggest overhang right now and why the stock can't lift its head. Question is how the capital is raised:
a) Warrant exercises (great)
b) Non-dilutive financing w/ $10 conversion price (2nd best, repeat of Iliad deal, conversion at $10 is better than dilution @ $2.80)
c) Dilutive share offering at prevailing market prices (3rd best, dilutes at a less than ideal share price, though better than back down at $.30)
Taking (c) above as the least ideal, but still helpful, let's say we need 6 months to get through HIV BLA & Covid. 25mm shares @ $2.50 = $62.5mm likely gets us there. 5% dilution for many times that in eventual share returns.
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