Replies to post #112950 on Cytodyn Inc (CYDY)

[SF Anony]

I totally missed that date. Good catch.

[bluefish1]

We will hear something. 28 days after the 195th patient was enrolled in CD12, an interim analysis will be done. The DSMC didn't say they wanted to talk to us again in 4 weeks. They said continue with the study, everything looks good.

We're not them.

[The oNiOnHEAd]

Interesting - How Aviptadil (a naturally occurring peptide) was discovered in the 1970's. Swiss Relief Therapeutics and the US-Israeli firm NeuroRx actually and rather brilliantly figured out that it could be put into a bottle and used as a medicine! They went on to deduce that adding a buffer, as well as stabilizers and preservatives actually extended the storage life!

From USPTO Patent # US8178489B2

Title: Formulation for aviptadil
Inventors: Gerald Bacher, Dorian Bevec

Abstract

The present invention relates to pharmaceutical formulations of Aviptadil and its derivatives. The stability of the Aviptadil formulation was shown to be improved by a formulation having a defined concentration of Aviptadil prepared in a buffer having a defined pH range.Claims:

1. A liquid, pharmaceutical formulation comprising 0.001 to 1.0% (w/v) Aviptadil in a buffer, wherein said buffer maintains the pH of the formulation at a pH of 4.8 to 6.7.
2. The liquid, pharmaceutical formulation of claim 1 which is substantially isotonic.
3. The liquid, pharmaceutical formulation of claim 2 which further comprises as stabilizer about 1% to about 10% a carbohydrate or a polyhydric alcohol.
4. The liquid, pharmaceutical formulation of claim 2 which further comprises a preservative.
...
20...."

And having a "defined concentration" begins stabilization of the peptide!

In words that I heard from the Director of the Patent Office of India, "You could take a piece of paper, fold it up in a new way, and the US Patent Office would grant you a patent for it." (para)