Texting while Sleepwalking
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The US might enter another lockdown depending upon tomorrow's outcome
Is more then 1 CRO common? If not, why would a company need more then 1 CRO? More then 1 country? State?
I like the IPIX reconfirmed based on the way things are going, human trials still on track for this Q
I think reality has sunk in. Pre-print is out. GMU and Rutgers have been named. Pre-IND complete with FDA comments. Human trials still to begin this Q
Last of the nervous nellies are selling into strength or flippers just unloading shares from .20. I suspect more then a slow burn by Friday, but I am no expert
Looks encouraging. Thank you
hope it's true. could result in a BO if DJT gets re-elected
good question. although when cytodyn was reported to have taken patients form their death bed to out of the icu, it did wonders for their reputation.
the hospitalization rates are on the rise. 120 patients won't be hard to accomplish. we just don't know the dosing/treatment plan. Is this a one time iv, several times over a certain period, etc... when is the interim analysis
i am glad the ceo used enough comments in the pr such as they are in agreement and that Q4 human trial is still the target now that the fda pre-ind comments are in
plus if the trial is still on track for this Q, in general agreement means pretty darn close if they have to impletement the fda's comments/suggestions into the study.
Got the pre-print
Got the pre-ind response
Now the arguing points should be when will the ind be submitted and is there 30 day waiting period. Will the holidays come into play somehow?
it's better then general disagreement
track some stats on the pre-print
https://biorxiv.altmetric.com/details/93484123
if you viewed the preprint on ipix's website, such as the link included in friday's pr, that view or share would not be counted
hoping to see the views/shares pick up this week by the science/health world
since the preprint appeared friday night/early saturday morning on biorxiv, the news was timed with the preprint submission
imho the email posted was a pm which is not allowed
there was a copy and paste of the email.
i don't see the c&p anymore, however this covers it
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159164981
I was under the impression there are no physical fda meetings but rather a written response only meeting based on the completeness and questions in the pre-ind package submitted by the sponsor
Didn't a poster share a supposed email from Leo dated Oct 23rd that they are still waiting for answers/comments on the pre-ind? if the email is legit/accurate, then the earliest possible date the IND could be submitted is Saturday, Oct 24th. Now the email could be disinformation to throw bears off or to show bulls that the pre-ind is still in process and to be patient
I actually find this part very interesting (and telling)
Exhibiting three-in-one properties—antiviral, immuno/anti-inflammatory,
and antibacterial—brilacidin is being developed for the intravenous treatment of COVID-19 in
hospitalized patients and may be able to address different disease parameters within the one
therapeutic treatment.
August 24th PR:
Lastly, the manufacturing of Brilacidin intravenous (IV) drug product is expected to produce an amount in excess of what is estimated to be required for the Company’s planned Phase 2 clinical trial, allowing for extra IV drug product to support potential additional COVID-19 clinical testing
There are some interesting leads in the footnotes
https://ghddi-ailab.github.io/Targeting2019-nCoV/preclinical/
Now that the pre-print is out, Brilacidin's SI value will be added to this list and when sorted by greatest SI, we'll be pretty close to the #1 position
A lot of suggestions lately, as well as referenced in the pre-print, that we need to, or eventually will, show up here:
https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials#activ1
ACTIV 1
It will evaluate the safety and efficacy of at least three immune modulators when given as an add-on therapy to remdesivir, an antiviral approved for treatment of COVID-19, and the standard of care in use at local clinics.
The authors of the pre-print alluded to pursuing B as a 3 in 1:
Exhibiting three-in-one properties—antiviral, immuno/anti-inflammatory,
and antibacterial—brilacidin is being developed for the intravenous treatment of COVID-19 in
hospitalized patients and may be able to address different disease parameters within the one
therapeutic treatment.
https://www.nih.gov/news-events/news-releases/nih-begins-large-clinical-trial-test-immune-modulators-treatment-covid-19
This is most likely our newly named consultant
Biotech Lab Systems Solutions Consultant
https://www.linkedin.com/in/weston-walker-5467983/
https://www.musatechnology.com/ (life sciences)
https://www.biomarin.com/ (therapeutics)
lmfao - i saw that too. i figured someone would have tried to pass that as warren
Warren Weston - seems this person is a consultant to Innovation Pharmaceuticals. Usually google is pretty convenient, but this time i haven't found anything obvious
Link to bioRxiv pre-print
https://www.biorxiv.org/search/brilacidin
This will take you to both brilacidin preprints; the top one is most recent
ipix seems to be on schedule. if you re-read the pr about ctap and early september, it says interactions. sending an email prior to the pre-ind is interacting. now that we know the pre-ind was sumbitted the last week of Sept/1st week of October that we are around 4 weeks and counting. My guess is all sponsors hear by week 6 in some way shape or form.... and who knows, maybe ipix was waiting for this unmasking of George Mason and Rutgers so they could address the fda's comments. Seems like the nda is no more
but seriously, who is warren weston at IPIX?
it would be lovely to get that PR rolling about inhaled Brilacidin being studied as a prophylactic
this seems like a big talking point
Additional formulation work is planned for the inhaled delivery of brilacidin for prophylactic use,
toward controlling infection in the nasal passage and lungs by leveraging brilacidin’s ability to
inhibit SARS-CoV-2 by disrupting viral integrity and impacting viral entry. Such development
efforts, if successful, may enable brilacidin to emerge as a particularly effective and differentiated
antiviral by preventing and/or decreasing early infectivity due to SARS-CoV-2.
Who is warren weston? He is listed as consultant to Innovation Pharmaceuticals
Well with ctap in place, they are not going to let a pre-ind sit around for more then 4 weeks without giving the sponsor feedback
It might be easiest to say 'waiting for feedback' in lieu of 'fda recommendations were not acceptable to us.'
I however believe we will be getting a positive update within 2 weeks. I doubt i will say this again in 2 weeks, but leo has been very good at issuing pr's that make me want to hang around a bit longer
We have the new contract hire / clinical trial manager. It still hasn't been clarified if she is here for Covid trials or something else. Assumption is that it's the brilacidin / covid study
Pre-print DD Link
https://icite.od.nih.gov/covid19/search/
This tool includes content from the preprint servers with the highest volume of papers relating to COVID-19: medRxiv, bioRxiv, ChemRxiv, arXiv, Research Square, and SSRN.
as we have seen, the ceo does respond to some select shareholders via email. it could be a fabricated email for entertainment purposes. it could be a real email. no way to know for sure as the company does not seem to respond to most investors. that's the perfect scenario for nefarious people to play with investor's emotions. nefarious is not solely allocated to describe toxic financiers or short and distort newsletters
i reminisce about the rapid grant meeting i think back in july and how secret messages were floating around that IPIX time had come. then those secret messages were shared here in a very cryptic way. Well, we know that not to be true since we are almost in November. games get played by both longs and shorts
i believe we will be getting a fda response within the next 2 weeks; how leo disseminates that info is up to him. there is no reason not to believe the human trials won't happen (triple negative go figure) based on previous pr's. it's just will ipix agree and be able to implement the fda's suggestions based on the pre-ind. i think so
obviously i hit a sore spot with you. why in the world would the rbl, in collaboration with ipix apply for a grant to expand into in vivo. your non reply to me says it all
barda requires in vivo testing, not just in vitro
barda is probably overwhelmed with preclinical therapeutics and have changed their requirements for up and coming therapeutics to show both in vitro and and in vivo. barda probably asks 'if your therapeutic is so good, why haven't you progressed to in vivo by now?'.... but but the RBL... doesn't matter. IPIX can go for in vivo results on their own and stop being so stingy. you got $6 million cash and another $30 million shelf.
i am reading a blurring of the pre-ind and ind process here
some, or at least one, has suggested that the pre-ind was basically the ind and that the 30 day period started from the pre-ind submission date. From the FDA May 2020 guide:
7 FDA’s review and
advice for the pre-IND meeting request will be expedited and prioritized based upon the
completeness of the submission and scientific merit.
8 Following review of the pre-IND meeting
request, FDA will work with the sponsor to help ensure that all necessary information has been
submitted. This pre-IND review will help result in a more efficient review of the subsequent IND
submission
https://www.fda.gov/media/137927/download
It's been about 3-4 weeks since submission; there is a footnote for #8 as it relates to CTAP:
For additional information regarding FDA efforts to prioritize review activities, see the Coronavirus Treatment
Acceleration Program (CTAP) web page at https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirustreatment-acceleration-program-ctap
there is no shortage of trial patients. just wait 2 weeks after thanksgiving to see another US surge and then an astronomical global jump after x-mas.
get ready to start stocking up on basic things like soap and tp now
Thanks for posting Leo's email yesterday as it relates to the pre-ind response. If he answered that basic question, I am sure the question "has in vitro testing at the rbl reached completion" been asked as well
curious to know the answer to that
i felt the same way. i did fast forward through some sections
it wasn't really a pitch on brilacidin per se, however it gives an idea what is going on behind the scenes at the rbl and it's almost up to the researcher the think critically. i just find it interesting in her linkedin profile, out of all things tested, brilacidin was the only one to make it in her profile. if find it interesting because she was also involved with the preclinical testing of maraviroc (pfizer) which had a nice write up in august
it was definitely a cryptic pr to say the least.
In reference to covid, is there such thing as a pre-ind meeting? I believe the fda doesn't have a meeting, but gives their input based on the company's questions and plan of action.
In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis.
I provided an example PR earlier today from another company and in that PR it had the fda's guidance and timing of when the company said they would be able to start a study based upon the fda's input. that was missing from the oct 2nd pr... however ipix through in the 'return of written responses, has been received" to throw us all off track
here's a recent video of the virologist who mentioned brilacidin on her profile - she might be the author (or one of them) on our study. around 4 min she starts talking about open access and pre print
What if the pre-ind written responses gave ipix the green light to proceed and ipix subsequently submitted the ind? we just don't know anything, good or bad.
the oct 2nd pr suggests the pre-ind submitted end of September and FDA provided written responses within 5 days. the quick turnaround would suggest a complete pre-ind package possibly indicating ipix is in agreement with fda's recommendation.
trying to read the smoke signals in the distance or am i just smoking tea leaves?