I think we are overthinking this. Company was alre
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Posted On: 09/29/2019 9:36:10 AM
I think we are overthinking this. Company was already running 525mg and 700mg data when they started BLA submission.
The BLA is for yet another combo drug of which there are many. FDA does not see major harm to patients in a 6 month delay for this. Also FDA is partially tax payer funded. Doing multiple stacked approvals for different doses ( 350,, 525, 700) for combo will cost more time and money. What's best for CYDY and shareholders is not of concern to them.
Mono and Cancer would be different stories. Here we have unmet need.
One positive of this is good 525 and 700 safety data makes FDA more comfortable in approving multiple phase 2 trials for many other indications.
The BLA is for yet another combo drug of which there are many. FDA does not see major harm to patients in a 6 month delay for this. Also FDA is partially tax payer funded. Doing multiple stacked approvals for different doses ( 350,, 525, 700) for combo will cost more time and money. What's best for CYDY and shareholders is not of concern to them.
Mono and Cancer would be different stories. Here we have unmet need.
One positive of this is good 525 and 700 safety data makes FDA more comfortable in approving multiple phase 2 trials for many other indications.
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