Can't agree more. Overlooked as "we already knew that" would be the following:
Read this paragraph again.
The Company is pleased to report that the results are also positive in the Microbiological Intent-to-Treat population (MITT). This is an important population, as it consists of patients enrolled in the trial who had cultures obtained at the baseline visit that were positive for common ABSSSI pathogens. Most of these cultures grew Staphylococcus aureus, and approximately 40% of these were Methicillin-Resistant Staphylococcus aureus (MRSA). This is currently the most important bacterial pathogen in patients with ABSSSI. As was seen in the ITT population, the primary endpoint in the patients with culture-positive ABSSSI was achieved for each of the three Brilacidin dosing regimens with similar results as for treatment with daptomycin for seven days.
This is bottom-line data. Of the upcoming Phase 3 trials, one will focus on MRSA, and please note we did not know that all 3 arms were as effective as 7 days of daptomycin.
If you read the above with the following and not separately,
In communication with the FDA last week, Cellceutix was encouraged to submit additional information from the Phase 2b study, including analyses of the recently obtained pharmacokinetic (PK) data. notice also that the clear link is the additional data that focuses on a breakdown of PK regarding each culturally identified type of ABSSSI causing bacteria. You suppose one breakthrough track will be highly resistant unresponsive strains? I would.
And how about this tidbit?
Cellceutix has received Institutional Review Board (IRB) approval to initiate its Phase 2 study of Brilacidin-OM, the Company’s novel oral rinse for the prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer.
Brilacidin-OM trial starts as soon as the clinics begin enrollment of patients. Clinical trials start begin with the study sites receiving the protocol and FDA Form 1572 (trial approval) and the IRB justification for the trial. IRB approval means all preliminary preparations are done. The last step before enrollment is the study initiation visit (SIV). The SIV is a pro forma visit by the sponsor simply to make final that all elements are in place at the study site. The first patient first visit (FPFV) is already in place along with advertisement and recruitment for the Brilacidin-OM trial. If the PR was written over the weekend, then the first patient is already being screened. Cancer therapy and treatment doesn't stop for week long holiday breaks.
This was huge and new news today that many treated as fluff.
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