Quote from Dr Bertolino's answer when asked by Kar
Post# of 72440
Quote:
As it stands currently for ABSSSI, we have planned a response to FDA for the Special Protocol Assessment, but we are delaying its submission. I'll explain why.
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That said, I believe that it is best for us to focus on the other more cost-effective trials at present and wait for upcoming milestones that can assist in recovery of CTIX share value so as to minimize dilution when raising capital for the ABSSSI trial. We already know that Brilacidin compares favorably to daptomycin in treating ABSSSI and have two other trials, oral mucositis and ulcerative proctitis, ongoing with the compound to further prove its merit in treating other indications. In my view, it is most prudent to circle back around to ABSSSI when we can draw upon available capital at a more shareholder-friendly valuation. Because of all the prep work, we can then squeeze that trigger and move forward expeditiously."
Leo has been very clear during LD Micro presentation recently that they won't proceed with the trial if there's no SPA. So now they're delaying the responses to FDA on the SPA.