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Posted On: 01/08/2022 11:58:15 AM
Post# of 145909
I only feel the BLA might have road blocks be cause I don’t feel like being optimistic when every solid prediction and fatalist ends up being less than anticipated. I have no actual knowledge that there are problems, just that it never seems to go as we think it should.
I do have faith in dr reckons, he does not seem to be the personality that accepts sloppy work. I am guessing that to work for dr reckoned is not easy as he checks the boxes as a perfectionist. Unfortunately he is inheriting the work others have done and has to fix it, instead of doing it right the first time. I also feel Nader and Scott can’t really be all that responsible for Amarex screwing up, the point of having an independent CRO is that the trial data is done with independent integrity. It is why biotechs hire CROs. Also, Amarex is a vendor, companies hire vendors when the need expertise, equipment and capability beyond what they have. We can’t blame those that hire a CRO for the CRO not delivering on what they sold them and for a process that must by design be hidden from the sponsor company to maintain integrity. However, I don’t understand that once the BLA was done the first time, it was not checked by an independent party to make sure it is correct. That I do blame Cytodyn for.
I do have faith in dr reckons, he does not seem to be the personality that accepts sloppy work. I am guessing that to work for dr reckoned is not easy as he checks the boxes as a perfectionist. Unfortunately he is inheriting the work others have done and has to fix it, instead of doing it right the first time. I also feel Nader and Scott can’t really be all that responsible for Amarex screwing up, the point of having an independent CRO is that the trial data is done with independent integrity. It is why biotechs hire CROs. Also, Amarex is a vendor, companies hire vendors when the need expertise, equipment and capability beyond what they have. We can’t blame those that hire a CRO for the CRO not delivering on what they sold them and for a process that must by design be hidden from the sponsor company to maintain integrity. However, I don’t understand that once the BLA was done the first time, it was not checked by an independent party to make sure it is correct. That I do blame Cytodyn for.
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