Posted on another board, I found this insightful a
Post# of 155125
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Posted On: 07/10/2020 4:06:48 PM
Posted on another board, I found this insightful as to why there might be increased silence and caution on the part of CytoDyn. It gels with NP's comment yesterday regarding it being sensitive times for CytoDyn as well. We have to be careful these next couple of weeks!!
https://www.accessdata.fda.gov/scripts/cdrh/c...the%20drug
https://www.accessdata.fda.gov/scripts/cdrh/c...the%20drug
Quote:
Sec. 312.7 Promotion of investigational drugs.
(a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.
(4)
(0)