Once again that is your opinion. Another soft bash of NP and management.
I can find blame in the DSMB’s evaluation for not changing our primary end point at the mid term analysis. If you look at most drugs tested and trialed the end point was changed to something they were sure they would achieve. That didn’t happen for us. Then most and if not all continue the trial for that achievable primary end point. You can say that we could of changed at the 75% interim review but the timing of the last part of the trial came so quick it wasn’t needed because of the increased speedy enrollment due to Dr. Reckons going on the road and drastically improving enrollment.
We would be sitting on a possible BLA if we it had changed to days recovered out of hospital when we received the DSMB recommendation. We still might get a gift in an EUA because we save lives better than everyone else in Covid trialed. The DSMB most definitely let us down. The change suggested to 42 days would not of helped us. I want a change recommendation from the DSMB that is a home run and if they did their job we had a couple of statistical significant end points we could of substituted to become our primary end point that were already in the protocol. We would be saving lives even with a different primary end point right now. Which suggests we had a pretty good idea in trial design. Most of the deaths and 80 of the total 88 deaths came before the 28 day end of the trial. That is proof that their addition to 42 days would of done nothing for us. Their recommendation would of not helped us on our primary end point going to 42 days. This is why no short is second guessing our 42 day suggested change. Because they know it didn’t matter.
Once again your opinion of the management is mostly wrong because 20/20 hindsight could be impressed upon any trial design. I would say in my opinion that you have no real ground to stand on in saying the DSMB isn’t a problem or the main problem we experienced. Because that is now obvious to me and others. Do you know what the job of the DSMB was? It was to find the help to pass with efficacy a primary end point that is quality enough to garner an approval of EUA or better yet a full BLA. We had end points that were possible to do that. The DSMB let us down at that point in the trial they were our only safety net and they let us fall completely through the net to the ground.
Being a soft basher is getting quite old to read all the time. I had you on ignore for a few months but who knows how many people you have scared out of their investment with your unfettered view of the CYDY management and our CEO NP.
I can find blame in the DSMB’s evaluation for not changing our primary end point at the mid term analysis. If you look at most drugs tested and trialed the end point was changed to something they were sure they would achieve. That didn’t happen for us. Then most and if not all continue the trial for that achievable primary end point. You can say that we could of changed at the 75% interim review but the timing of the last part of the trial came so quick it wasn’t needed because of the increased speedy enrollment due to Dr. Reckons going on the road and drastically improving enrollment.
We would be sitting on a possible BLA if we it had changed to days recovered out of hospital when we received the DSMB recommendation. We still might get a gift in an EUA because we save lives better than everyone else in Covid trialed. The DSMB most definitely let us down. The change suggested to 42 days would not of helped us. I want a change recommendation from the DSMB that is a home run and if they did their job we had a couple of statistical significant end points we could of substituted to become our primary end point that were already in the protocol. We would be saving lives even with a different primary end point right now. Which suggests we had a pretty good idea in trial design. Most of the deaths and 80 of the total 88 deaths came before the 28 day end of the trial. That is proof that their addition to 42 days would of done nothing for us. Their recommendation would of not helped us on our primary end point going to 42 days. This is why no short is second guessing our 42 day suggested change. Because they know it didn’t matter.
Once again your opinion of the management is mostly wrong because 20/20 hindsight could be impressed upon any trial design. I would say in my opinion that you have no real ground to stand on in saying the DSMB isn’t a problem or the main problem we experienced. Because that is now obvious to me and others. Do you know what the job of the DSMB was? It was to find the help to pass with efficacy a primary end point that is quality enough to garner an approval of EUA or better yet a full BLA. We had end points that were possible to do that. The DSMB let us down at that point in the trial they were our only safety net and they let us fall completely through the net to the ground.
Being a soft basher is getting quite old to read all the time. I had you on ignore for a few months but who knows how many people you have scared out of their investment with your unfettered view of the CYDY management and our CEO NP.
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