Replies to post #134075 on Cytodyn Inc (CYDY)

[BBalls-N-CowTown]

Nov 23 (75% day) + 28 days?

[weasel6667]

After a quick search I cannot find this requirement (EUA in country of origin) on the webpage of the FDA Philippines.
https://www.fda.gov.ph/category/circular/
I assume they would mention such an important and fundamental requirement on their own webpage!

This is what the FDA announced as condition for EUA:

VI. SPECIFIC GUIDELINES

A. Conditions for Issuance of the EUA

The EUA shall only be issued and remain valid only when all of the following circumstances are present:

1. Based on the totality of evidence available, including data from adequate and well- known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19;
2. The known and potential benefits of the drug or vaccine, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of the drug or vaccine, if any; and
3. There is no adequate, approved and available alternative to the product for diagnosing, preventing or treating COVID-19.
The last condition is deemed present when there exists no registered drug or vaccine in the country for diagnosing, preventing or treating COVID-19.

There is no better description about our beloved Leronlimab!
Especially number 3 fits our CD12 trial to 100%

[tradinplaces]

Misi,

This is outside of my wheelhouse, I don't know what the DSMC is allowed to do or not allowed to do. It would be outside of the norm but would it be prohibited for them to have a peek at the data? It seems that if there are any conscionable folks on the DSMC, they might be taking a personal interest in getting Lero to market in light of the whole covid situation and may draw outside the lines a bit.
Also, with the highly successful professionals on our team who we have now, I find it a little suspect that they would have missed a detail in the Philippine filing situation like the fact that they had to have an EAU to be considered. It seems more plausible that our team anticipates that EAU within the two-week timeframe that NP spoke of which goes hand in hand with the DSMC stopping the trial theory.

[Lilbrother]

From what I've read the partner in Philippines gets us around that. Basically our partner which is local is bringing the drug to the Philippines. So they can get an eua..