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Re: DesireToLearn post# 155613

Saturday, 07/23/2016 11:01:25 AM

Saturday, July 23, 2016 11:01:25 AM

Post# of 402932
As I understand it, the current budget was figured on the basis of having already initiated a Phase 3 for Brilacidin. If the Phase 3 is on hold, then the cash outlay is also delayed don't you think?

Here is the situation as I see it. Almost out of nowhere Mr. Ehrlich hired Dr. Bertolino.

"Dr. Bertolino held positions as Senior Medical Director and Senior Director of Dermatology at Pfizer, Inc. Among other accomplishments at Pfizer, he led clinical programs for over a half-dozen new chemical entities involving Phase 1 and Phase 2 studies and contributed to planning for Phase 3 studies. Dr. Bertolino led FDA clinical interactions at entitlement meetings for Pfizer's dermatology products and served as Pfizer's dermatology spokesperson.

There was likely significant interest shown for Prurisol based on the Phase 2a data. Because 2 of the 3 the dose ranges missed on the low side, a likely partner wants to see if dosage can be increased without a side effect. I would wager that is the reason for the 2b. I personally believe it's very likely that Dr. B was brought on primarily to broker the sale of Prurisol upon a successful Phase 2b. Of note, the Phase 2a for Prurisol was completed ahead of schedule and was over enrolled as well. ( Guess the demand is there, Huh.)

In the mean time the "jackpot" play of GI indications for Brilacidin can be investigated via less expensive Phase 2 trials. All IMHO.

LEGEND OF ABBREVIATIONS
B = Brilacidin, the antibiotic
K = Kevetrin, the oncology drug
P = Prurisol, the psoriasis drug
SAE = Serious Adverse Event
IND = Investigational New Drug


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