I think many now consider me somewhat of a loose cannon on the board but that is in no way my intention. I do, though, feel the board needs to address areas of concern and I have many. No longer am I of the opinion that "Leo will do it" with no discussion of whether he is doing a good job or not is something that is verboten on the board.
The PR a couple of days ago solidified IMO the many, many varied uses for Brilacidin against many viruses and bacteria, Covid still being a major player in this realm.
But the PR left me stone cold stunned with the following statements and made me wonder what the hell they have been doing for the last 8 months. The info in red below is right from the PR:
Efforts to advance the Brilacidin Oral Mucositis (OM) program are a key focus. The Company is presently exploring timelines and scenario planning—including the option to seek a meeting with the U.S. Food and Drug Administration towards the initiation of a Phase 3 clinical trial evaluating oral rinse Brilacidin as a new treatment for the prevention of OM in head and neck cancer patients receiving chemoradiation. Brilacidin oral formulation development work for Ulcerative Colitis continues. The Company has also been notified by Alfasigma, its licensing partner, of their intent to initiate this year Phase 2 testing of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis.
1. We have been told a P3 for OM would begin Q1 '22 for quite sometime and now the company says they are JUST NOW planning a MEETING with the FDA for such a trial. JUST NOW A MEETING?"??"? All I can say is WTF happened? Isn't Brilacidin supposed to be Fast Tracked??? And yet a year or so after the P2 we feel a meeting is now a possibility to discuss a P3? To me this is gross incompetence at best as the P3 is most likely now lucky to get started by late '22.
2. The pill for IBD without the special sauce from BDD still in the works though that was deemed not that hard when IPIX decided to go this new route. So basically next to nothing for IBD has been done in the last year and since we will need a P1 for the pill prior to a P2 or even if they allow a P1/P2 to be run together i again feel we are looking at the end of '22 at best for such a trial to begin. I take it someone is helping us formulate this pill - are they a 2 person company as well because they also seem not to be able to move things past the starting line.
3. AlphaSigma - All they had to do was come up with a gel/foam/ etc and here we are about 2 years down the road and they sit at square 1 with the Q1 '22 planned P2 now moved out to sometime this year, again I consider that most likely the end of the year. Did Covid wipe out all cases of postsigmoid colitis to move the clock back so drastically ??? I think not. So IMO this supposedly decent sized pharma is no better than IPIX in getting things moving.
I know this post will piss off most people but if so, tell me what I am missing.
Makes me also wonder why we even have a rental space in Watertown MA since nobody is there, at least I hope no one is there as there is no need for them)
So as to the PR - yeah, the trial data improved greatly but what we were told in the PR makes me think we haven't got jack **** going on in the only area that could quickly change our fortunes as to being able to raise money.
As to the raising funds question, Brilacidin hasn't proved itself yet to the powers to be (BARDA, INH, etec) to at least have gotten us in the pool for possible funds. Again, we are planning to submit to a number of different govt sources for funds. NO ACTION HAS HAPPENED, we just again are planning.
So WTF has been happening to progress our company on any front?
The talk about purchasing additional assets IMO makes it sound like we have a crazy "Putin" type character at the helm divorced from reality.
I don't feel I am being overly critical because IMO NOTHING has been accomplished in quite awhile while everybody is still getting paid handsomely as though they are breaking their asses getting things done.
The PR a couple of days ago solidified IMO the many, many varied uses for Brilacidin against many viruses and bacteria, Covid still being a major player in this realm.
But the PR left me stone cold stunned with the following statements and made me wonder what the hell they have been doing for the last 8 months. The info in red below is right from the PR:
Efforts to advance the Brilacidin Oral Mucositis (OM) program are a key focus. The Company is presently exploring timelines and scenario planning—including the option to seek a meeting with the U.S. Food and Drug Administration towards the initiation of a Phase 3 clinical trial evaluating oral rinse Brilacidin as a new treatment for the prevention of OM in head and neck cancer patients receiving chemoradiation. Brilacidin oral formulation development work for Ulcerative Colitis continues. The Company has also been notified by Alfasigma, its licensing partner, of their intent to initiate this year Phase 2 testing of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis.
1. We have been told a P3 for OM would begin Q1 '22 for quite sometime and now the company says they are JUST NOW planning a MEETING with the FDA for such a trial. JUST NOW A MEETING?"??"? All I can say is WTF happened? Isn't Brilacidin supposed to be Fast Tracked??? And yet a year or so after the P2 we feel a meeting is now a possibility to discuss a P3? To me this is gross incompetence at best as the P3 is most likely now lucky to get started by late '22.
2. The pill for IBD without the special sauce from BDD still in the works though that was deemed not that hard when IPIX decided to go this new route. So basically next to nothing for IBD has been done in the last year and since we will need a P1 for the pill prior to a P2 or even if they allow a P1/P2 to be run together i again feel we are looking at the end of '22 at best for such a trial to begin. I take it someone is helping us formulate this pill - are they a 2 person company as well because they also seem not to be able to move things past the starting line.
3. AlphaSigma - All they had to do was come up with a gel/foam/ etc and here we are about 2 years down the road and they sit at square 1 with the Q1 '22 planned P2 now moved out to sometime this year, again I consider that most likely the end of the year. Did Covid wipe out all cases of postsigmoid colitis to move the clock back so drastically ??? I think not. So IMO this supposedly decent sized pharma is no better than IPIX in getting things moving.
I know this post will piss off most people but if so, tell me what I am missing.
Makes me also wonder why we even have a rental space in Watertown MA since nobody is there, at least I hope no one is there as there is no need for them)
So as to the PR - yeah, the trial data improved greatly but what we were told in the PR makes me think we haven't got jack **** going on in the only area that could quickly change our fortunes as to being able to raise money.
As to the raising funds question, Brilacidin hasn't proved itself yet to the powers to be (BARDA, INH, etec) to at least have gotten us in the pool for possible funds. Again, we are planning to submit to a number of different govt sources for funds. NO ACTION HAS HAPPENED, we just again are planning.
So WTF has been happening to progress our company on any front?
The talk about purchasing additional assets IMO makes it sound like we have a crazy "Putin" type character at the helm divorced from reality.
I don't feel I am being overly critical because IMO NOTHING has been accomplished in quite awhile while everybody is still getting paid handsomely as though they are breaking their asses getting things done.
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