Sunday, November 23, 2014 7:38:05 PM
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:
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.
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