Ritz Let’s not blame the FDA on this one. If my
Post# of 155592
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Posted On: 01/06/2022 10:46:40 PM
Ritz
Let’s not blame the FDA on this one. If my memory serves me correct, NP wanted to submit this when we had three patients and was told that a larger group was needed.
Then a while later, CYDY submitted without significant superiority to the SOC.
We are already on thin ice with the agency and this waste of time submission does not improve that situation.
I would hope and expect that if we made a proper submission with 6 months more survival it would be approved.
If we made a proper submission that would be a first for our company.
As I said bad start to the year - it needs to get better from here - we certainly all expected better and we’re disappointed - AGAIN
IMO
Let’s not blame the FDA on this one. If my memory serves me correct, NP wanted to submit this when we had three patients and was told that a larger group was needed.
Then a while later, CYDY submitted without significant superiority to the SOC.
We are already on thin ice with the agency and this waste of time submission does not improve that situation.
I would hope and expect that if we made a proper submission with 6 months more survival it would be approved.
If we made a proper submission that would be a first for our company.
As I said bad start to the year - it needs to get better from here - we certainly all expected better and we’re disappointed - AGAIN
IMO
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