Texting while Sleepwalking
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Is a pre ind required? I will look for the fda link later that talks about being able to go straight to the ind so long as you can submit a complete package and being able to get a quicker response then 30 days. Its the page that refers to briefing packages and the fda only providing wro as responses vs in person meetings or teleconferences.
sounds nice. stochs have been oversold for quite some time. would be nice to get a multi day run/pop
Looking good
Maybe that crossed market in the pre mkt was a sign after all lol
Surprised this recent Aug publication for Kevetrin wasn't mentioned either
https://cancerres.aacrjournals.org/content/80/16_Supplement/3613.short
google scholar comes in handy.
Looks like fda only accepts brifing packages now instead of having preliminary meetings and issue wro's (written responses) instead of meetings.
C'mon ipix show us what early September means...
Do we think IPIX would PR 1) the RBL is done and 2) CTAP interactions? Seems the PR's lately suggest getting into human trials urgently would mean IND this week. I too get the 30 day period confused. I know others have said it does not take 30 days from IND being approved to start human trials. I am not referring to compassionate use. I guess we need to know the CRO and hospital selection is all lined up as well as the IV B for C ready to go to assume it would be any faster than 30 days. also is the IV B for C necessary prior to the IND? Doesn't seem like the type of news that will go bing, bang, BOOM
GM. Here is the link. I searched for our gmu researcher, Aarthi Narayanan, to find this
https://www.biorxiv.org/content/10.1101/2020.08.12.246389v1.full
Who knows if Brilacidin was mentioned at any point to PFE to put us on the radar. Strictly speculation based on the tweets that were coming out of rumorville about a month ago.
https://www.google.com/search?q=Maraviroc&rlz=1CABASQ_enUS893US893&oq=Maraviroc&aqs=chrome..69i57j69i61&sourceid=chrome&ie=UTF-8
Pinksheet stocks are a tough sell, but not impossible. IPIX doesn't have a rosy past of being able to execute. The amount of news that has come out compared to the PPS says the market doesn't really believe in B for C. I think once the FDA gets involved and not a variety of unnamed labs (RBL, PHRI, University) then the PPS goes on to make new heights. Maybe the unveiling of all the labs involved when the preprint is made available will have a positive impact on price along with confirmation of data investors have seen to date via vague PR's.
Trying to rationalize why there was no PR stating the RBL is done. Was testing delayed? Is testing done? Was it determined additional data was needed? I am not a long time investor here but it is clear the ceo is not one to disclose 'not so great info.' Is everything happening so slow? Is everything happening so fast that it's best to collect all the pieces before issuing the next PR for the best impact? Are we waiting for pre-print before issuing next PR to avoid the doubting Thomas?
IPIX will have it's day in the sun (or more likely a good run). We are all being exhausted by the dwindling pps yet amazing potential. i chose to pre-occupy myself so as not to watch tick by tick possibly 2nd guessing my decision to believe in B for C as well as the pipeline. TIme will tell. In a month i am happy to say i was wrong.
September catalysts:
CTAP update
IND confirmation; human trial start date
RBL collaboration grant
CRO and CDMO selection
Hospital selection
Confirmation IV brilacidin is ready
Pre-print being made available
other possible scenarios that i don't recall IPIX mentioning
-Grant money for human trials (someone correct me if i am wrong other than the Barda news back in Feb)
-collaboration
-partnership
-sale of company or disposition of asset
hints at other possibilities
-compassionate use
-extra IV drug product to support potential additional COVID-19 clinical testing
-Inhaler with Electrostatic Sterilizer and Use of Cationic Amphiphilic Peptides
-remdesivir / brilacidin study
Thanks. The key is not to freak out in the home stretch even with the dwindling pps. Glad people are able to buy on weakness cause imho the pps will be much higher this time next month.
Yup that is 1 of the 2 pre prints I posted yesterday. Brilacidin is getting attention with the big pharma boys. If you type in narayanan in the pre print servers you will find another article highlighting a pfe drug, which the wording is very familiar to our Aug 24th pr.
sort of reminds me of ktov back in april. they were about to have a drug launch but the stock kept going down and down. then one day out of the blue, the stock decides to pull a 180 and start going up by decent percentages. the market is here to take adavatage of the lemmings because their suspense accounts have unlimited funds to do whatever they like. retailers, especially penny players, do have a threshold of common sense after a while....i think
Doctors should understand confidentiality, right? IPIX is an easy target to smack talk. I get it. Really I do. For all the potential catalysts this month, IPIX is drifting lower. Your POV is what the market sees. They get it too.
The bar is being set soooooo low here compared to the rest of the covid 19 plays. I am amazed on a daily basis, but i am easily amused
the easiest DD now is just to type brilacidin in the following popular pre print servers
BioRxiv (https://www.biorxiv.org/)
ChemRxiv (https://chemrxiv.org/)
medRxiv (https://www.medrxiv.org/)
SSRN (https://www.ssrn.com/index.cfm/en/)
Brilacidin is starting to show up again as of late August. The wording in the latter Aug PR's has me feeling Leo is seeing the light and will do his best to get our IND filed asap as well as those pre print server links
I understand for the long time investors here that the reappearance of DeGrado is a big step, but let's be clear, he's on the scientific advisory board. He's not management. He's not on the BOD. He's on the sab to help guide us. RBL and/or PHRI probably had specific questions that DeGrado was best suited to address and hence his reemergence at IPIX. I am sure Leo and Bill are friends, but business is business and confidentiality agreements have to be in place in order for Bill to answer those questions.
It's not a problem. I have posted the CTAP link several times in the last few days
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap#:~:text=Vaccines%20(ACTIV)%20Partnership-,What%20is%20CTAP%3F,they%20are%20helpful%20or%20harmful.
Please refer to the CTAP dashboard statistics. The world is up against a virus with hundreds of potential avenues to tackle covid 19
I can then ask you to refer to the Aug 24th IPIX PR where our in vitro data has us in the 20 drugs. Brilacidin didn't make the initial list 5632 compounds. We were a nobody then and now that the RBL is done, we went from not being in the recognized 5632 compounds to now being in the top 20.
June 17th IPIX PR: "Testing results observed to date formed the basis for a federal grant application that was submitted last week by the RBL, in collaboration with the Company, proposing to evaluate Brilacidin’s potential as a pan-coronavirus therapeutic, with possible extension into other viruses."
June 11th IPIX PR: "The proposed research aims to evaluate Brilacidin as a potential pan-coronavirus therapeutic, for treating SARS-CoV-2, SARS-CoV-1 and MERS-CoV, including extending the current in vitro testing of Brilacidin to in vivo testing. Longer-term objectives include potentially performing additional research to develop Brilacidin as a broad-spectrum antiviral, with possible application beyond coronaviruses, e.g., treating other viruses, such as encephalitic alphaviruses and filoviruses."
It's all in the PR's
We are all anxiously awaiting the RBL grant news as it relates to the RBL collaboration. Other than the Feb BARDA announcement, has IPIX said anything about getting grant money for themselves? CTAP news on deck
I 2nd that motion
Covid 19 has given many poorly run drug stocks a 2nd chance at life. Ipix liquidity has increased greatly since February due to covid 19. We are literally days, not weeks, away from finding out if ipix can execute a strategy for covid 19. If not, we have to wait for drug trials to start up again for other indications. This is not an ipix specific delay. Its affecting many pubcos.
I am sure that is correct but remember nefarious people go away for vacation too. I have been part of epic squeezes right before a holiday weekend. I enjoyed the etoys holiday weekend squeeze greatly back in the 90's
Agreed. Who knows, maybe there is a pr ready to go. Just waiting for confirmation from fda our ctap package was accepted. Thats a pr that doesn't come out at 830am. Its on the fdas schedule
That's the exciting thing here. We just don't know when. I just posted the CTAP FAQs. They check multiple times per day for new applications. An upcoming holiday next week doesn't stop them from working the rest of the week.
Per the June 5th GMU announcement, the Aug 24th IPIX PR and the call I had with IPIX, we have the information necessary for an IND. I will take IPIX's 'early September' comment literally. It did not say first half of September, but rather it said early September (to me meaning sooner than later, but i can always be happy with it meaning before Sept 15th as well). I don't believe a pre-print is a requirement of CTAP so long as we have all the information necessary to inform CTAP
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap-frequently-asked-questions
LOL - there are many ways to interpret it, whether we look to the stars/solar system or take it literally. To me it says we'll hear in the standard turnaround time... What is known is the RBL and PHRI already used federal grant money to study Brilacidin so we will have complete information on our CTAP app (not operation warp speed as others have vented about here) and then we also know IPIX kicked in an extra $35k to get the EC50 value for our IND.... that in and of itself has us joining a list of only 19 other drugs.
Watch some of the more popular preprint servers
I posted 2 articles yesterday that show we are getting closer. Brilacidin has been showing up more and more lately as a potential therapeutic along with only a handful of other more commonly known drugs. Google scholar search is also another good source
BioRxiv (https://www.biorxiv.org/)
ChemRxiv (https://chemrxiv.org/)
medRxiv (https://www.medrxiv.org/)
SSRN (https://www.ssrn.com/index.cfm/en/)
7465 Articles alone (from medrxiv and biorxiv)
https://connect.biorxiv.org/relate/content/181
I spoke with company on the phone a few weeks ago. They said based upon current turnaround times, we should hear back on grant specified in the June PR around mid-September. As things are open for interpretation, the phrase around mid-September does not imply a specific date
Thank you
here's an aug pre print for narayanan on a drug being developed by pfe. wonder if where that rumor about a month ago started. could have been part of the same GMU research for brilacidin.
aug 30th
From this information and knowledge of other viruses like HIV-AIDS, Ebola, Influenza, Hepatitis C, or Malaria (4, 5), we have suites of anti-viral and other compounds that can potentially mitigate the damage of the virus on the body, including Remdesivir, Tocilizumab, Favipiravir, Galidesivir, Brilacidin, and Dexamethasone (5). In particular, Remdesivir, which resembles the structure of an HIV reverse-transcriptase inhibitor, has shown promise for reducing recovery time of patients in acute stages, and the steroid Dexamethasone, used widely to fight serious inflammatory reactions, was shown to reduce Covid-19 deaths. Drugs that block spike, membrane, or envelope proteins on the viral shell of coronaviruses are actively being sought, and some are being investigated in clinical trials.
https://www.biorxiv.org/content/10.1101/2020.08.28.271965v1.full
The twisting of truths is pretty interesting to watch. The in virtro preclinical data was handled by an rbl, but let's not mention that. Let's focus on a new advisor to the company, one of the discoverers of brilacidin as a reason why ipix will fail in some way, shape or form. Too funny.
The pr mentioned submitting ind early september so mid October could be realistic if ind is approved and cdmo and cro are up and running full speed. Lots of moving parts. Better to be realistic than emotional at this point. Its going to be an exciting 2 weeks imho
Ind has 30 day review. Not sure if ctap would shave any time off review
Let the fireworks begin: RBL, CTAP, IND, $$
September will be a good month for IPIX
Brilacidin didn't make the top 5600 initially but we are about to scream from the mountain tops we are one of the top contenders now that the rbl is done. Look at the research that has gone into the 19 drugs that article pinpoints. We are about to join that list ina big way.
Ipix is here trying to better and save lives. We are all human. We all make mistakes and we then learn from them. Current management and new addition(s) are welcome with their experience. Exciting times are coming real soon
CTAP news for brilacidin will get this party started. Brilacidin received fast track designation previously for other conditions. RBL data and previous P1 data will seal the deal. Grant news will be icing on the cake.
The next 2 weeks will have some exciting back to back trading days. Should be fun.
Big 2 weeks coming up
Glta.
Degrado's comment "Additionally, Brilacidin has progressed through Phase 2 clinical trials, including one in which it was administered orally for the treatment of Oral Mucositis."
There is hope there might be a non IV P2 trial or use. Not holding my breath, however gotta keep hope alive