my understanding/takeaways from the proactive vide
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Posted On: 08/06/2020 4:08:03 AM
my understanding/takeaways from the proactive video yesterday FWIW...
1. Hope for FDA to approve m2m for EUA and proceed with a Ph4 study based on what is believed to be statistically significant efficacy results.
2. Efficacy topline results for m2m to be announced next week. So that everyone understands, this WILL BE CONFIRMATION of efficacy. It SHOULD create excitement resulting in some 'big media' coverage. Maybe we also get some BP agreements conditioned on EUA.
3. Significance of DSMC recommendation to continue lost on CYDY investors, including myself. Safety is a known non-issue to investors such that the DSMC reiterating it is a non-event.
4. Significance of less SAEs in drug group vs. placebo group in m2m lost on CYDY investors. Mainly because the OUTSTANDING SIGNIFICANCE of this result was not focused on/highlighted/emphasized in calls or in the press release. The need to emphasize this significance to investors likely missed by NP and JL because it was so obvious to them that they assumed it was so for everyone.
I cannot fathom how anyone who looks into leronlimab wouldn't come to the same conclusion the longs on this board has. I don't see a failure mode for my investment except for the FDA regardless of statistically significant results. I watched Dr. Been show with Dr. Yo on as guest last night and was impressed with the 8 point scoring system Dr. Yo uses to rank/evaluate clinical relevance of all the drugs being investigated for use against CV19. They are mechanism of action, safety, efficacy, route of administration, where in the developmental phase, exclusion criteria, price, and scalability. As he was going thru these, I couldn't help but think that leronlimab ranks very high on all of these. Sure I have reason to be biased, but I think any objective person seriously investigating leronlimab would come to the same conclusion.
1. Hope for FDA to approve m2m for EUA and proceed with a Ph4 study based on what is believed to be statistically significant efficacy results.
2. Efficacy topline results for m2m to be announced next week. So that everyone understands, this WILL BE CONFIRMATION of efficacy. It SHOULD create excitement resulting in some 'big media' coverage. Maybe we also get some BP agreements conditioned on EUA.
3. Significance of DSMC recommendation to continue lost on CYDY investors, including myself. Safety is a known non-issue to investors such that the DSMC reiterating it is a non-event.
4. Significance of less SAEs in drug group vs. placebo group in m2m lost on CYDY investors. Mainly because the OUTSTANDING SIGNIFICANCE of this result was not focused on/highlighted/emphasized in calls or in the press release. The need to emphasize this significance to investors likely missed by NP and JL because it was so obvious to them that they assumed it was so for everyone.
I cannot fathom how anyone who looks into leronlimab wouldn't come to the same conclusion the longs on this board has. I don't see a failure mode for my investment except for the FDA regardless of statistically significant results. I watched Dr. Been show with Dr. Yo on as guest last night and was impressed with the 8 point scoring system Dr. Yo uses to rank/evaluate clinical relevance of all the drugs being investigated for use against CV19. They are mechanism of action, safety, efficacy, route of administration, where in the developmental phase, exclusion criteria, price, and scalability. As he was going thru these, I couldn't help but think that leronlimab ranks very high on all of these. Sure I have reason to be biased, but I think any objective person seriously investigating leronlimab would come to the same conclusion.
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