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Posted On: 03/30/2021 10:42:56 AM
Post# of 148984
Superjoo wrote:
It's very important to determine whether the FDA controlled the dosage or did Cytodyn control the dosage? Can someone with experience clarify this point. No opinions or conjecture on this question please. Let's clear up this question once and for all.
my response:
from what I've read (not on FDA websites) I thought the Cytodyn proposes trial protocol and the FDA looks at the protocol, approves it or suggests changes etc. We did have our early eIND data with its dosing to look at. If we had just given 4 doses we'd have hit a grand slam homer and LL would be famous today, gettin folks off ECMO etc. etc. etc.
It's very important to determine whether the FDA controlled the dosage or did Cytodyn control the dosage? Can someone with experience clarify this point. No opinions or conjecture on this question please. Let's clear up this question once and for all.
my response:
from what I've read (not on FDA websites) I thought the Cytodyn proposes trial protocol and the FDA looks at the protocol, approves it or suggests changes etc. We did have our early eIND data with its dosing to look at. If we had just given 4 doses we'd have hit a grand slam homer and LL would be famous today, gettin folks off ECMO etc. etc. etc.
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