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Posted On: 08/22/2021 3:17:03 PM
Post# of 148892
Figgs, first BBQBBQ now you.
LL is not going to get approved in the US because doctors know about it.
It is going to get approved or at least EUA if we have statistically significant p values in double blind placebo controlled studies. Especially in light of the FDA letter and the extra scrutiny because of the Alzheimer’s drug debacle we need results not media attention. Media attention could help the stock price but not get LL approval.
Since we are not an approved drug for other indications, doctors cannot even prescribe off label.
The quickest and best way to approval is the old fashion way - good clinical trial results with quality regulatory submission docs.
Cydy does not think approval is imminent - we cancelled our agreement with our US distribution partner.
That is not to say that we couldn’t quickly ink a new deal but your suggestion for doctors awareness won’t work for LL approval.
IMO
LL is not going to get approved in the US because doctors know about it.
It is going to get approved or at least EUA if we have statistically significant p values in double blind placebo controlled studies. Especially in light of the FDA letter and the extra scrutiny because of the Alzheimer’s drug debacle we need results not media attention. Media attention could help the stock price but not get LL approval.
Since we are not an approved drug for other indications, doctors cannot even prescribe off label.
The quickest and best way to approval is the old fashion way - good clinical trial results with quality regulatory submission docs.
Cydy does not think approval is imminent - we cancelled our agreement with our US distribution partner.
That is not to say that we couldn’t quickly ink a new deal but your suggestion for doctors awareness won’t work for LL approval.
IMO
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