Avid Bioservices Inc (CDMO)

[Big On Tarvy]

"If so, what really excites me about PPHM is that there is so many indications for the same drug. We could see PHII?III for multiple cancer indications, Bavi fast tracked for DTRA Hem Fever, DUKE with a early use as microbicide all at once."

From what I hear, this statement is very close to the mark, except that:

1. The Phase 2-3 trial for 300-400 patients that is filed with the FDA this summer will be for either lung or breast cancer, not both;

2. This Phase 2-3 trial will cost around $30 million spread out over two years and will be funded mostly/entirely with revenues from gov't stockpiling of Bavi for military use (hemorraghic fever?);

3. Two mini-trials of around 20 patients each will also start this summer/fall to see how Bavi does against hard-to-treat patients, i.e. breast cancer patients where all are HER2+ and lung patients where all are squamous cell.
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IMHO, the Company would not have told all the analysts at Cowen conference that "high profile Duke paper" will be published before June 30 unless this had been confirmed first with Haynes.

IMHO, the "market" will pay attention to this stock starting in April,May and June due to the combined impact of AACR India clinical updates, Duke/Haynes pulbication, two ASCO abstracts with concurrent clinical updates from all three Ph II trials, and filing with FDA in June/July for Ph 2-3 trial for 300-400 lung or breast patients.

IMHO, the key difference between us and other biotechs who negotiate BP licenses at the end of Ph II is that Avid will be generating enough revenue in 2009 and 2010 from gov't and other contracts to pay for most/all of the Ph 2-3 trial. The ability to fund a Ph 2-3 trial ourselves gives us huge negotiating leverage with BP. My personal guess is that we will file the FDA applications ourselves and start down the path of running the Ph 2-3 ourselves, but after jacking up the price tag we will let BP run the show. In fact the ideal time to close the BP license/partnership might be in the three month period after the FDA application is filed and before it gets approved to allow the BP to put its stamp on the final clinical protocol.