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Posted On: 09/30/2020 8:55:54 PM
Post# of 148908
Thanks Trding. It is frustrating to learn about this new hurdle to filing a complete BLA.
In reviewing the information you provided, it seems that any and all information related to the Receptor Occupancy Test is also related to the monotherapy trial.
1. Is this correct?
2. Does this somehow signify that FDA is looking more deeply than "just the combo approval?"
It doesn't seem possible that CYDY could apply for a combo approval and then get a mono approval. Maybe FDA knows that patients and doctors might "go rogue" and try mono on their own? Trying to see if there is a certain profile that might indicate that mono could work vs. another profile that would indicate it is too risky?
In reviewing the information you provided, it seems that any and all information related to the Receptor Occupancy Test is also related to the monotherapy trial.
1. Is this correct?
2. Does this somehow signify that FDA is looking more deeply than "just the combo approval?"
It doesn't seem possible that CYDY could apply for a combo approval and then get a mono approval. Maybe FDA knows that patients and doctors might "go rogue" and try mono on their own? Trying to see if there is a certain profile that might indicate that mono could work vs. another profile that would indicate it is too risky?
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