Like most on this board, I am stunned that with 2
Post# of 72440
I believe Brilacidin did not fail the recent Covid trial but that the setup of the clinical trial (and IPIX mgt accepting the setup of the trial) as failing Brilacidin and the American public in bringing this drug to market. IMO the medical community is culpable for tens if not hundreds of thousands of deaths due to Covid worldwide. I base this on the mysteriously fast approval of very questionable vaccines, the stonewalling of new therapeutics and the handling of therapeutics in their entirety in regards to the Covid situation, the rigidity of the clinical trial program that causes undue delay in advancing promising treatments, the expected payola to many, many people in the whole medical bureaucratic system, and the lack of physicians demanding a change in the current monolithic system.
Do I sound pissed off? I hope so because I am irate over the whole situation.
Let's look at the history of Brilacidin to make my point. It was developed nearly 20 years ago (20 YEARS!!!!!!!), 2002, as that is when Polymedix was founded. Yet with all the history of research of its wonderful properties here we sit with no commercial applications for it yet. The government needs more testing of it even though the DeGrado Lab at UCSF has been researching defensin mimetics since 2013 and Brilacidin is considered the foundational drug of this new arm of medicine. Anybody else see a major problem here? It was shown to be superior to Daptomycin as a new age antibiotic that was pretty much immune to bacterial resistance and yet it has been shelved for many, many, many years due to lack of funds to run a phase 3 trial even though we keep hearing about the calamity of superbugs developing that can overcome all current antibiotics. I say the 3000 patient trial number the FDA is total BS and the lack of funds is a disgrace when the govt just gave Billions upon Billions to BPs to try and revamp their current load of outdated POS drugs to work against Covid. Typical government waste (or payobla) throwing money right down the crap hole. The invitro lab results of B against Covid were spectacular yet the trial was run at a far reduced dosage to that dosage IPIX wanted it run (at least that is what I have been led to believe). As to the trial, when they stopped it after 25% patients were enrolled to evaluate going from 3 to 5 days of dosings, they had to have seen the poor results to date but the committee of dolts didn't suggest upping the dosage in a possible new arm to see if that was the problem? No, they let it run out so that now to find if that was the problem a new trial would have to be run and thats another years delay, but hey, its only people still dying so what's the problem, right???
As for mgt, if the dosage was taken down by the FDA why didn't they also demand that the results be reduced drastically since they had to expect the results would be far less impressive than what the full dosage would have returned. Makes me wonder what the hell is Harkness doing as isn't she the trial person? After Prurisol and Brilacidin trials, I'd sack her ass in a heartbeat.
Bottom line - It seems quite evident that for IPIX to succeed and our drugs have any chance of seeing the light of day that we will be required to have a "favored" partner by the medical/government establishment. Another way of saying "greasing the right palms" IMO. If Leo hasn't figured this out yet maybe time to get rid of him. He has suffered nothing with his pay still quite robust (and has been all these last 10 years or so) and his "need for speed" is lacking IMO
No way in hell I believe it has taken this long for secondary/CU data to be collated as the data was locked in early Nov. I am hoping some major developments or even minor developments are revealed later this month but I am dreading all we hear is more time needed for further study and months to go before we hear of any grant money or some type of governmental money coming in.