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Monday, April 10, 2017 3:11:50 PM
Interview With New Cellceutix President Dr A Bertolino
https://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino
Q: Shareholders are frustrated with the pace of development of Brilacidin for ABSSSI. Can you give me your view on Brilacidin and moving it into a pivotal clinical trial?
"A: For starters, from what I've learned about Brilacidin recently, it is an incredibly promising drug for many, many applications. I believe that Brilacidin is a drug that is an ideal example where multiple potential indications can evolve in parallel as I mentioned earlier. It is also currently in active clinical trials for oral mucositis and ulcerative proctitis. The most effective strategy for further development will likely emerge once we have perspectives across all of these indications.
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.
In my limited time so far at Cellceutix, I have been debriefed on all ongoing communications with the FDA and other pharmaceutical companies. I know that there is interest from different companies for different compounds in the pipeline. We are estimating that Phase 3 studies will cost approximately $30 million over about two years, which means we need to raise some additional capital to conduct that research and move forward with all the other drugs we're developing. I also believe that the Cellceutix share price is artificially depressed because of: a lawsuit that we believe was without merit yet took time and resources to reach its recent dismissal; and a generally negative bias towards the biotech sector on Wall Street.
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."
In Reply to 'Amatuer17'
That was not the point - it was the twist and flip flop carried by Leo.
If the P3 for B-OM need higher number of patients and needs higher cost - Leo may drop B-OM like he dropped B-ABSSI - and may move to B-UP P2b as new alternative
He has shown his liking for jumping onto new trials without taking a single product to completion
Look at market response - yawn
As market just does not believe in his big PRs
Any other company with good B-OM and possibility of BTD
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