Followers | 134 |
Posts | 7040 |
Boards Moderated | 0 |
Alias Born | 02/09/2012 |
Sunday, June 27, 2021 5:21:57 PM
Reviewing this commentary:
"The majority of the few hundred patients treated with brilacidin so far experienced adverse events, some of them serious."
... Some "tingling" in "some" patients, not a majority...could be recategorized (misrepresented) as an "adverse event" which was resolved promptly AND there was NO conclusive evidence that "some" blood pressure issues deemed "SAE"...and where occurred it was resolved almost immediately with meds. NO SAE TIED TO BRILACIDIN. (muddies up the water)
"If brilacidin ever gets used in a few thousand patients, then we'll have a better idea of its safety profile, but it doesn't look good so far."
... Always get a "better idea" with more patients...but you ABSENT FORM THE STATEMENT ...BRILACIDIN/COVID TRIALS ARE FOR PHASE II..."EFFICACY".
IN FACT BRILACIDIN SKIPPED PHASE I "SAFETY" because BRILACIDIN HAD ALREADY PASSED SAFETY HURDLE ... and ALSO DID SO WITH and AFTER ABSSSI TRIALS...
"In the meantime, there's no Phase III data to show it even works."
Referencing "no Phase III" to show that it works...OBVIOUS OBSERVATION... BUT...also another OBVIOUS OBSERVATION ik that IPIX/BRILACIDIN IS IN PHASE II, and was just completed...IT IS AN "EFFICACY STUDY"...and will of course reflect more safety data...but it is PRIMARILY EFFICACY...from which EUA could be granted! Phase III could be done concurrently with the EUA administration.
PS A high-profile Brooklyn hospital administrator has stated to me that numerous serious liver complications have developed in patients to whom Remdesivir was administered. NO FORMAL REPORTING has taken place to CDC, since reporting is on a "voluntary" basis, patient to patient...
Nice way to hide a very SAE, for the time being...but that NEWS will eventually come out. The thought process was "pick your poison"...better to risk damaging the liver than let the patient potentially die. Thank you Dr. Fauci...
IMO if BRILACIDIN DOES NOT DEMONSTRATE SAE...i.e. liver damage ... and meets its minimum goals...it will be deemed a HUGE THERAPEUTIC SUCCESS.
PPS. While we wait for Trial Results...As Per PR...UC Trials appear to be on the runway...IMO could be multiple BP watching and influencing the protocol for those trials UC and Crohn's definite unmet need. A potential BLOCKBUSTER with IMO BP all over it.
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
FEATURED POET Wins "Best Optical AI Solution" in 2024 AI Breakthrough Awards Program • Jun 26, 2024 10:09 AM
HealthLynked Promotes Bill Crupi to Chief Operating Officer • HLYK • Jun 26, 2024 8:00 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM