they did change endpoints to be in line w NIH remdesivir studies
they said an interim analysis would pause the trial and enrollment is going well , should be fully enrolled by EOM and full data will make more robust presentation so they are skipping the interim.
howdy, BorelFields. HGEN did change the primary endpoint for their P3 trial from mechanical ventilation + mortality to "time to recovery." At the same time, they boosted the planned sample size from 238 to 300 and tightened the enrollment criteria to push the cohort towards the more severe end of the spectrum. Despite the company spin of "making the endpoint more in line remdesivir's," I took the changes as a bad sign...the effect was not going to be clear enough without boosting the sample size and changing the primary endpoint. Also, Dale Chappell said there would be some "slippage" in results, away form the lovely "effects" reported for the initial 12 Mayo patients in the EIND preprint.
On the other hand, I think the recent data from Mayo are much more promising than the market seems to think, especially in light of the changed endpoint.
I bought some shares before the 08/03 conference call but had serious doubts w.r.t. the endpoint and sample size changes and about the the whispers of substantial share dilution in the not-too-distant future. I kept my shares, though, on the implicit "recommendation" the FDA gave by selecting lenz for BET. I still think it is a good bet for covid-19 success, but maybe I should have waited until next week to buy!
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