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MinnieM

11/16/17 1:55 PM

#203980 RE: baytdr #203969

There's no contradiction since my post was dealing with Brilacidin for ABSSSI. Todays pr was about Brilacidin for OM.

Both indications are dosed quite differently. ABSSSI treatment is IV and that makes it more high risk as a new class of antibiotic. That's likely why the FDA ok'd moving forward with the ph3, but, with a more robust trial than the company had anticipated.

OM treatment is a simple swish and spit. Plus, there is no competitor with an approved product for prevention of OM.

The playing field is quite different for the two indications.

Time will tell.





In Reply to 'baytdr'
today's PR seems to contradict what Leo said to several of you at 2015 Biotech Showcase. There has never been a PR for B Absssi like today's PR for B-OM so whats the current difference in the development stage of B Absssi and B-OM, assuming B-OM top line proves to be as good or better than interim?

The only way to square this is to conclude that there is more competition facing the marketing of Absssi, including off patent competition and that PIII will be much more expensive than B-OM so the offers were not adequate or FDA guidance was not helpful and there were no offers.


"Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results.

“We very much look forward to taking what could be the final step in Brilacidin’s development for the prevention of OM—top-line results reporting followed by possible advancement into a pivotal Phase 3 trial,” said Leo Ehrlich