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Posted On: 05/20/2021 4:23:24 PM
Post# of 148899
I have been saying this for awhile, and maybe people here don't understand, and that's ok too.
Regardless of whether someone likes or dislikes management, it is immaterial to my post. So please refrain from utilizing pro or con if responding to my post.
No one at Cytodyn is capable, as in having past experience or proficiency, in developing trial protocols. Amarex was hired not just as our CRO, but to fill the gaps of knowledge we lack, such as developing and submitting trial protocols, determining which people might be most ideal to fill the necessary roles (virologist, biostatistician, etc..) in our DSMC's. Cytodyn, as the sponsor, bears all responsibility in both hiring of Amarex, and in retaining them in light of multiple failures of trial design.
The 4 dose vs 2 dose debate could have been solved via a quick escalating dose study just to appease the FDA. But as I've pointed out, we have no one with such knowledge. Amarex should have guided us with more appropriate advice in that regard....yet they didn't. Asking for 4 doses, well after trial initiation is not the same as submitting a lengthy trial protocol that needs to be evaluated and approved. Once again, we relied on Amarex to perform these necessary functions.
I guess my ending point is that, it would be ideal if we had "someone" in-house who can perform the functions necessary to setup a "proper trial design" as opposed to relying on a company like Amarex.
Regardless of whether someone likes or dislikes management, it is immaterial to my post. So please refrain from utilizing pro or con if responding to my post.
No one at Cytodyn is capable, as in having past experience or proficiency, in developing trial protocols. Amarex was hired not just as our CRO, but to fill the gaps of knowledge we lack, such as developing and submitting trial protocols, determining which people might be most ideal to fill the necessary roles (virologist, biostatistician, etc..) in our DSMC's. Cytodyn, as the sponsor, bears all responsibility in both hiring of Amarex, and in retaining them in light of multiple failures of trial design.
The 4 dose vs 2 dose debate could have been solved via a quick escalating dose study just to appease the FDA. But as I've pointed out, we have no one with such knowledge. Amarex should have guided us with more appropriate advice in that regard....yet they didn't. Asking for 4 doses, well after trial initiation is not the same as submitting a lengthy trial protocol that needs to be evaluated and approved. Once again, we relied on Amarex to perform these necessary functions.
I guess my ending point is that, it would be ideal if we had "someone" in-house who can perform the functions necessary to setup a "proper trial design" as opposed to relying on a company like Amarex.
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