BioVie Inc (BIVI)

[someconcerns]

Hi Gov,

I know you are impatient with IPIX progress and feel that their management has been too slow.

In defense of Leo and Menon over at IPIX, BIVI has a known drug which has been observed, while in off-label use, to dramatically reduce ascites and to have negligible safety risks. Jonathan - the BIVI CEO - is very methodically dotting every "i" and crossing every "t" in running thru the steps the FDA needs to see to show that the drug (approved in Europe but not in the US) is safe and has the effect of reducing ascites. In a more logical world, the FDA would have looked at the data from Europe and said "sure, lets approve the drug."

Jonathan initially started with capital from a few founders, added to the shell of the company into which it was merged and then collected more capital from angel investors, myself (and perhaps yourself?) included. After that, Jon moved on to a similar deal with Aspire for incremental financing as Leo did.

At IPIX, Leo has Kevetrin and Brilicidin which are both novel drugs, Prurisol is a novel formulation of a known drug used for HIV. FDA is really just making IPIX jump thru more hoops than BIVI, IMHO. EDIT: WE know Dana Farber was extremely slow in doing the Ph1 study. I do not think that was Leo's fault.