Maybe I got it wrong on the HIV BLA CRO being chan
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Posted On: 09/12/2021 2:30:02 PM
Maybe I got it wrong on the HIV BLA CRO being changed.
Maybe the reason for the new contract is due to the expense of the additional chemistry tests requested by the FDA.
Tropism test costs around $3k.
If the FDA asked Cytodyn to conduct tropism tests on a hundred patients not previously tested for tropism, that could be $300k and the reason a new contract is needed.
It Cytodyn didn't do tropism tests on all of its trial participants, this could be the reason for a delay of a month or two assuming there is some frozen blood available for test.
Tropism tests are not relevant to any aspect of the study results.
If Cytodyn didn't test for tropism and chose people at random, 95% of them would have the CCR5 variant that is useful for the study.
If some non-R5-tropic patients did get into the study, then if you do a tropism test today and take them out, the results will get even better because non-R5-tropic patients will not respond to leronlimab.
Maybe the reason for the new contract is due to the expense of the additional chemistry tests requested by the FDA.
Tropism test costs around $3k.
If the FDA asked Cytodyn to conduct tropism tests on a hundred patients not previously tested for tropism, that could be $300k and the reason a new contract is needed.
It Cytodyn didn't do tropism tests on all of its trial participants, this could be the reason for a delay of a month or two assuming there is some frozen blood available for test.
Tropism tests are not relevant to any aspect of the study results.
If Cytodyn didn't test for tropism and chose people at random, 95% of them would have the CCR5 variant that is useful for the study.
If some non-R5-tropic patients did get into the study, then if you do a tropism test today and take them out, the results will get even better because non-R5-tropic patients will not respond to leronlimab.
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