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Re: HyGro post# 206023

Tuesday, 03/22/2022 5:59:39 PM

Tuesday, March 22, 2022 5:59:39 PM

Post# of 236733
Covid results were good for the critical subgroup but formally speaking we cannot determine efficacy on that basis due to the small sample size. However that trial informed us how we should refine the patient requirements, the endpoints and that we must have 4 doses. We convinced ANVISA on the new design and they approved. Unfortunately we got a bit unlucky since by the time we finally got approved by ANVISA, the situation in that country had drastically improved and our enrollment came to a standstill. So our chances to prove in that indication before funding issues became too urgent were gone and now things are moving slow (we think). Of course, longs are still hoping those trials can be completed and we will know the results soon. CoV chapter for LL is not closed unless and until Brazil verdict is out.

(To add generally: I am also concerned regarding the patients we will get at this time, since I thought we were best positioned to prove the worth of LL (and separate from other medicines) against the cytokine-storm scenarios of the Delta variant. The trial protocols in Brazil seemed specially designed for this purpose. Now we are dealing with a less-aggressive variant and the patients who become critical may do so more because of the mix of comorbidities (than primarily the viral cytokine aggression) for which LL may not be as effective. Hopefully we get a suitable patient pool.)

I agree that things are not clear about the cancer (and NASH) data.

HIV for what I understand is still open ground for us to make a mark. The first question is whether LL can secure approval based on the completed trial, vindicating its 81% efficacy, and enter the market. That is a leap from where we are right now and that is what longs are betting on happening. Things you predict are for much after; a lot of things can turn our way by then.

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