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Tuesday, December 23, 2014 12:51:32 PM
-Cohort 10 news for Kevetrin: updates will be presented January 12th. I suspect it will be part of the year end summary of events and progress.
-Phase 3 news for Brilacidin ABSSSI--FDA meeting outcomes including fast-track definitions: updated that the FDA wants more PK data before a final decision on Phase 3 trials. This is actually good news as the use of plural states that there will be more than one Phase 3 Brilacidin trial and implies the additional trials will go beyond ABSSSI. Leo can't state this directly until CTIX meets with the FDA and receives guidance and approval.
-Phase 2 start and protocol Brilacidin OM--FDA meeting outcomes including fast-track definitions: IRB approval is the same as the start of recruitment and treatment. Again, updated to say the information will come on January 12.
-Phase 2 or 2/3 news Prurisol: Another update that the information will be January 12.
-All 4 of the above.: Sorry if this is confusing. It was meant as a multiple choice reference as in "or all of the above", not that all of the above would come in December.
Please be aware that I have already stated my satisfaction with yesterday's update as it contained some bottom line data including and especially that Brilacidin was equal to Dapto 7 days across all 3 arms including the lowest dose. No matter what others may have stated, we did not know that until yesterday's confirmation. That .6 mg/kg will eliminate all AEs other than those few people who can be easily screened for sensitivity.
I'm not a trader looking for quick profits on a Santa spike. I hold a large position and continue to hold that position. Nothing in the PR to disappoint.
I once got high with Joe Cocker.
I know he appreciated this little video.
Joe for Rock and Roll Hall of Fame and
God rest his sole.
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