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Monday, October 12, 2020 8:40:52 AM
Background info:
IPIX PR Aug 24:
Interactions with the Food and Drug Administration , through its Coronavirus Treatment Acceleration Program, are anticipated to begin early September, along with the selection of a Contract Research Organization to implement the Brilacidin for COVID-19 clinical trial.
FDA July 14th CTAP update:
Preliminary, partially-formed inquiries go to them before they are assigned to product review teams to determine next steps for engaging with the FDA, including what regulatory submission is appropriate, what to include in that submission, and how to submit it.
https://www.fda.gov/news-events/fda-voices/update-and-behind-scenes-fdas-coronavirus-treatment-acceleration-program
IPIX PR Oct 2nd:
Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that earlier this week the Company submitted a pre-IND meeting request to the FDA
My interpretation
At the end of August, Leo hints that IPIX is sprinting toward human trials in Q4. We all assume September (at least me) that we'll be getting the big CTAP update stating IPIX has been given the green light for human trials asap. September comes and goes without any human trial update, which is pretty much a let down for all. Upon further frustration, a re-read of the past PR's for the umpteenth time shows that Leo never said an IND app would be submitted to the FDA, but rather "interactions." Those interactions were preliminary (just look at the ctap link provided). Obviously the preliminary back and forth with CBER/CDER experts on hand was sufficient enough to have a complete pre-IND package submitted most likely at the end of September (according to the Oct 2nd PR)
Now if IPIX had it's own twitter account, these could be official updates vs. issuing a PR that has to add a bunch of other information to make it look more impressive other than saying Pre-IND package accepted by FDA with written responses expected shortly. Also a tweet could have gone out in early September that interactions currently underway with FDA with Pre-IND package to be submitted by end of month would have help calm investors nerves and not try to hypothesize what is going on such as did they submit a pre-ind or just go for the ind, did they decide to wait for the rbl to finally finish before contacting the fda, did leo buy a lambo or bently, etc...
At this point, when B for C shows up here, we should see another epic run https://clinicaltrials.gov/ct2/home
The pre-print will be great. I am still not sure if GMU is the RBL because some of the recent pre-prints i have seen out of the 'narayanan lab" in August make not mention of B out of the 22 drugs they are screening. GMU got our EC50 value per their update.... but we are not sure if they are in fact 100% the rbl doing the extensive testing. That was my concern about why the suffolk county dinner party stated that gmu was indeed the rbl... now it could be the rbl who tested b combined with r, but i don't see that update coming out of ipix or gmu.
GLta
the above is all IMHO (consider this my safe harbor statement)
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
SANUWAVE Announces Record Quarterly Revenues: Q3 FY2024 Financial Results • SNWV • Nov 8, 2024 7:07 AM
DBG Pays Off $1.3 Million in Convertible Notes, which Retires All of the Company's Convertible Notes • DBGI • Nov 7, 2024 2:16 PM
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