Replies to post #217581 on Cytodyn Inc (CYDY)

[justdafactss]

Did CYDY ever divulge the reason for the hold?

According to the FDA its got to be one of these---

Some examples of reasons for clinical hold are shown below:

Product Quality:

Product has an impurity profile indicative of a potential health hazard or an impurity profile insufficiently defined to assess health hazard

Product cannot remain chemically stable throughout the testing program

Pharmacology and Toxicology:

Data from animal studies are not sufficient to support the anticipated exposure (dose, route of administration, and duration) for the proposed clinical trial

Poor quality non-GLP toxicology studies with difficult to interpret results and a safety signal that has not been sufficiently studied are proposed as pivotal toxicology studies to support use of the product in humans

Clinical:

Previously observed toxicities of the product are not addressed by the proposed safety assessments in a clinical protocol

For a product with a high potential for an unpredictable acute reaction, all subjects are dosed at the same time without consideration to staggered administration.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold