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3X Charm

04/25/21 8:40 PM

#161634 RE: LifeLongLearner #161626

the intel on CYDY cancer trials is appreciated and you make fair points. I will be with a Pharma CEO tomorrow and his COB. I will see if I can get some hands on intel on trial design, adaptive studies, conducting trials outside of US. I already had feedback on HIV RTF and it was a poor grade. I live in in Tampa, you know the Super Bowl and Stanley Cup champs. I was partners a RE deal with the CYDY CEO prior to Nader. It’s a long shot we know each other.

Glad to shed whatever light I can.


If FDA is messing with CYDY is it from prior experience with BLA or something more nefarious? I know what I heard about that.
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DonDonDonDon

04/25/21 8:52 PM

#161638 RE: LifeLongLearner #161626

At least a portion of my intel comes from having a friend in the cancer trial. In that example Dr. Jay has been trying to get the FDA to increase the dosage for close to a year.


Makes one wonder if it is because efficacy is low. They wouldn't be asking for a higher dosage if efficacy was great.
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misiu143

04/25/21 9:29 PM

#161652 RE: LifeLongLearner #161626

LifeLongLearner ., and I believe the cancer dose Dr Lalezari want to use on cancer patients is 700 mg and FDA is refusing .,

700 mg , when we treating so many patients already with different diseases with this dose , but no , FDA make Dr Lalezari still use 525 mg on this cancer patients for now .,.
FDA refusing to ok for him to use 700 mg in basket trial ..

How one may explain this ., how this is not investigated and they not in jail .,

I don’t have any explanation of FDA behavior very often..

All imo