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biodoc

11/23/14 7:38 PM

#79312 RE: vip1999 #79306

I'll take a stab at this but I very much look forward to hearing thoughts from Karin, BK, and others.

Yes, Leo almost certainly has bottom line results and has formulated a strategy for the FDA meeting. I may be wrong but I think Leo could release the data right now. IMO, it makes more sense to release it after discussing full results with the FDA.

Obama's recent Executive Order to combat antibiotic resistance directs the government to 'reduce the emergence and spread of antibiotic resistance.' From the Sept 19 PR:

Cellceutix believes this Presidential Order could not arrive at a better time and is optimistic that the data from the trial will demonstrate that its novel defensin-mimetic platform shreds bacteria quickly with little-to-no chance of resistance developing. Cellceutix believes positive data will position it perfectly to move forward quickly not only with Brilacidin, but its entire defensin-mimetic portfolio with support from the new Presidential Order



It is likely that Leo has strong ideas on facilitated pathways and other incentives that are appropriate for Brilacidin development, especially with so much attention focused on antibiotic resistance. However, until the FDA blesses his plan (or some other plan), it makes sense not to highlight the results without a well defined course of action. I think Leo has given us every indication that the data is very good- but he is not yet certain as to how FDA will want to move forward.