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Posted On: 03/10/2021 12:39:42 PM
Post# of 148936
“Closet, If I remember correctly and at the end of the fda's analysis, they definitely asked for the data for the Mono-therapy trial as well and at that time, they already had all the data from the Combo, no?”
Again, refer to the combo trial only having 47 patients at completion. That size of trial will never receive approval from the FDA (see CD12 results from 62 patients). CYDY should’ve run a larger phase 3 combo trial at 350mg if they expected a quicker approval from the FDA.
The RO data is somewhat confusing. We know that NP is not an honest CEO, so the RO data may have been a requirement from the start and CYDY just didn’t have it.
Again, refer to the combo trial only having 47 patients at completion. That size of trial will never receive approval from the FDA (see CD12 results from 62 patients). CYDY should’ve run a larger phase 3 combo trial at 350mg if they expected a quicker approval from the FDA.
The RO data is somewhat confusing. We know that NP is not an honest CEO, so the RO data may have been a requirement from the start and CYDY just didn’t have it.
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