Texting while Sleepwalking
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It's called alloprime. forget the name of the company. My point of posting the collaboration is it's an indirect benefit to IPIX. If you read the PR put out by GMU and the one put out by NLS, and look at what IPIX has said about GMU furthering research on Brilacidin, IMHO it's a pretty solid fit. We need expedited pre-clinical research and that seems to be what NLS can provide
Look up NLS. They are working with an israeli company on a pan-viral vaccine. if you read the various pr's on the new collaboration as well as GMU furthering it's research on Brilacidin, including pan-corona virus and in vivo testing, as well as other topics noted, it seems NLS would be a benefit. They collaborate with GMU, not IPIX (as per the PR). IPIX would get the benefit of this collaboration IMHO
New CRO / GMU collaboration
dated Dec 21st (any coincidences with IPIX)
https://www2.gmu.edu/news/2020-12/mason-announces-collaboration-noble-life-sciences-antiviral-and-antibacterial-research
“Access to the BSL-3 facility through this collaboration agreement with Mason will enable NLS to provide preclinical testing services in support of an immediate need for the development of coronavirus vaccines and therapeutics as well as other emerging infectious diseases,” said Srujana Cherukuri, Chief Executive Officer at NLS.
https://noblelifesci.com/
https://noblelifesci.com/news/collaboration-with-george-mason-university/
that was sort of an unexpected positive response. Registering the study is a good first step. Fulfill those ethical obligations to update the medical community, potential partners/collaborators, patients, granting institutions
IMHO if IPIX is still going for grant money, the first thing after the IND went active would be to REGISTER the study. Shows the dosing. Let them compare it to the pre-clinical data and prior study dosing outcomes. Show the hospital/trial sites that have already signed up. I mean, if it's in a PR it must be true (cue the safe harbor statement and pinksheet stock comments)
My thought process is if in the middle of November before we had an active IND IPIX had a schedule and that human trials were on track for 2020. It would be nice to know what assumption ipix was under to start trials within 6 or 7 weeks. Maybe that was assuming a Nov 3 ind submission and 30 days later is roughly Dec 3. Is this the miscalculation? About 2-3 weeks behind?
Nov 2nd: The Company anticipates commencing the Brilacidin for COVID-19 clinical trial in 4Q2020.
Nov 16th: Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.
Nov 30th: Missing
Dec 21st: Missing
What happened between Nov 16th & Nov 30th? Something happened along the way to P2. Just like something happened to the grant in collaboration with the RBL. The grant didn't have enough data and the RBL had an unnamed internal blip that caused the delay, so filing a premature grant app had nothing to do with IPIX.
IPIX calling for human trials with 6 or 7 weeks left to the year and then act like it was never said? I would love for there to be secretive trials going on and hospitals willing to go along with the shroud of secrecy even though there is an ethical obligation to report the study. Makes sense
IPIX really tried to rally on anticipation of news from the end of Nov into early Dec. We rallied off a low of .155 to .20
Then we get a SEC filing about more dilution. Yes, IPIX is a pinksheet stock, sorry OTC stock, that needs to tap the market to raise cash. The stock then tests the prior low of .155
Leo to the rescue let's investors know the IND is approved. The stock forms a double bottom at .155 and this time rallies above the previous high of .20 and hits .221
In anticipation of Leo following his word of a Q4 trial start date, IPIX tries to rally past .221, however silence takes over as end of year selling and/or dilution are the main trades taking place. Yes, there are 2 sides to a trade, so when someone sells that means someone buys. However there is still more selling pressure leading bulls to say things like "I'll throw out a stink bid" instead of saying "slap that ask!!"
Calls for a PR each and every day of 2021 have come and gone. The important thing is for the current low of .171 to hold (short term price action)
These price points are from stockcharts.com.
I gave a link to search many major global study registries yesterday. Nothing listed. Every person is different and when people defend the CEO as being too busy, I would like to say there are way more influential people in the world then Leo and they take the high road to update their communities, whether is be stock market, schools, police, mayors, food stores... what have you. Leo can update us as to the DELAY I spoke of yesterday. What delay?
The worst excuse is 'delay'
It is the worst excuse because there is no reason, but we just need to take comfort in the word 'delay'
Don't focus on the numerous times IPIX stated Q4 but just focus on the upcoming word 'delay' without reason. Remember, it's never a 'delay' caused directly by IPIX, but rather a delay caused by a 3rd party.
Maybe someone can track down the nearing 2 month old overseas CTA app: https://www.who.int/clinical-trials-registry-platform/network/primary-registries
https://apps.who.int/trialsearch/
Here is another global DD link to see if you can find Brilacidin in a Covid study: https://www.who.int/clinical-trials-registry-platform/the-ictrp-search-portal/external-search-platforms
How we looking?
http://www.ipharminc.com/newsroom-1
Like I said, WAT
I know you a firm believer in IPIX
What I see is a pinksheet stock and Rule 504D in conjunction with recent SEC filings
Once I see the ethical obligation to the medical community to register the study, the WAT will have been proved incorrect. That's it. No need for insulting comments
Just a WAT (replace guess with theory)
IPIX raised the cash to pursue the other indications while using the B for C ploy to get us to this point. I have to assume a forward looking analysis was done and IPIX is looking at how much more they have to spend to prove B for C to get any attention in the field, as compared to IPIX trying to further along the other indications closer to the finish line
If they wanted to be a Covid player, they would have registered the study by now as active, not recruiting. imho Ipix is not in hiding from short and distort newsletters to only surprise the market with great results as the next pr. ethics is the first reason listed as to why a sponsor should list their study to educate the patients and market
i am happy to be proven wrong
21 days from Dec 21 is January 11th (theoretically)
When the company didn't PR the CRO or the CDMO, I assumed neither were in place
Supposedly the drug is already manufactured for this trial (with excess for add-on studies) and multiple CROs in place
I can't make heads or tails of the way IPIX reports it's news. I doubt there are any patients enrolled to date, but that is just a guess
I am not a believer in the concept of an IPIX trial currently underway and will update investors up the 21 days from the 1st patient enrolled. It's a nice thought however.
Doesn't mean I am correct, but it's my opinion
it's a possibility. back on Dec 21st the company said we are up to the site initiation visits, meaning US sites have already been selected. The pr suggested additional sites might come in to play, but as the conversation lately has touched on, how many sites do you need to recruit 120 covid patients inclusive of domestic and abroad?
As of Dec 21st, IPIX had enough information to register this study domestically as active, not recruiting.
PR or not, the study still needs to be registered
https://www.clinicaltrials.gov/ct2/home
I don't like making excuses, but I think some (both bulls and bears) acknowledged getting an approval late December would then run into the holiday schedule resulting in delays... hence now the excuse
over the holiday i did go to fedex to try and ship something from Florida to Cabo. Priority overnight first available was 5 days later. UPS was very even longer.
I recall some of the more educated IPIX longs having a discussion about this after the 426 SI came out. It was waaaaaaayyy over my head but i think if you look back, some were trying to extrapolate a number based off of items contained in the pre-print
You kindly posted this link before
https://medium.com/@TheRealDanSfera/what-is-a-site-initiation-visit-in-clinical-research-bb1b5653a53a
We do have to read between the lines here between the 12/21 pr and this information. Leo basically said site(s) are selected and now is the home stretch before patient enrollment
I can see the holidays getting in the way of timely delivery of B to the trial sites (IND approved just days before x-mas and new years) as well as arranging convenient times with the lead investigator.
Fingers crossed. Not a fan of using this phrase when money is on the line
So you are saying there were no pre site visits? Ipix always had a very aggressive position to start trials asap even prior to submitting its ind
GM. Thanks. Based off the info we have so far are we able to determine if the Covid dosing would be the same (or lower) as the low dosing group from that study?
The FDA didn't see any issues with this P2 trial. We had used prior studies to move past P1, so any SAEs would have been covered imho
Appreciate the quick tutorial. I guess we'll find out in P2. Most likely will come up at the interim results if it's an issue or not
hypertension. the previous study i can find any hyperstension info on said 6 of 160 patients receiving B showed signs of hbp. 3 of these patients were in the high dose group. The 1 patient in the low dose group reporting having pre-existing hypertension. maybe i am looking at the wrong study. thanks
"Fulfill ethical obligations to participants and the research community"
That is the #1 reason listed as the purpose of registering your study
https://www.clinicaltrials.gov/ct2/manage-recs/background
Can I register a study after it has started, has closed to recruitment, or has been completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant
https://www.clinicaltrials.gov/ct2/manage-recs/faq#registerIND
Is Leo too busy to register the now approved trial? I have heard rumors from significant shareholders they introduced Leo to another RBL that could have sped up the process by 2 months however Leo burned that bridge. Another RBL. Not some independent lab, but a US Goverment RBL just like GMU. Any hoo, at least we are at the P2 starting line. Let's see how it unfolds
Ipix perked up again this year because of Covid
Covid plays are still hot... just like EV and Bitcoin
The Covid data so far seems good for IPIX, but it's preclinical. Right now we are the turning point of getting into human trials. It's a risk/reward play. Will our lead Covid drug candidate do well in human trials? That's a gamble you have to make
Other reasons why the stock is not yet in rally mode. The company PRs are not very direct, but give more or less a general idea. Many times investors are left with more questions then answers. The time frames given in company PRs are not to be relied upon. The company disappears when bad news arises. Toxic financing has hurt the share price without concrete news to back it up.
Positives include our now active IND, a pre-print out of George Mason Univ and Rutgers covering our lead Covid drug (however not peer reviewed yet), cash in the bank, Covid drug has already been manufactured, several CROs in place (domestic and overseas) to start trials
Speculation include grant money, new partner/collaborator, update on other indications, good P2 results, new arms included in clinical studies for pan-coronavirus, new pre-prints coming out on lead Covid candidate
Happy New Year
LOL - Happy and Healthy
never imagined i would still be here
other then the headline by a 3rd party, i am having a hard time finding where Russia says they developed it. 50/50 chance it is Brilacidin. The timeline fits with the CTA and all the pre-clinical data released by GMU
At no point does it say it's been tested in humans
As much as I would love to have more concrete info on anything P2 related, I will grasp at this straw in the meanwhile
happy and healthy
The volume is kinda thin if you ask me. Could be flippers who had a few shares hoping for a quick grandslam. Last year was profitable for many traders and now is the time to off set gains.
If we see volume perk up to a few million by end of day, we can speculate further
It's an experimental pre-clinical drug
that keeps checking the boxes for Brilacidin. Not saying it is, but sometimes there is truth to some of the stuff that gets smeared around here
circling back to russia and a new antidote
https://www.zerohedge.com/medical/russia-develops-highly-efficient-antidote-fight-covid-claiming-99-effectiveness
would be one heck of a coincidence if it were Brilacidin
Penny stocks are still running lately even when they are shrouded with failure(s) of some sort. I agree the immediate future of IPIX relies heavily on a successful Brilacidin / Covid P2 study, especially in early to mid Feb when the 2nd round of conversions happen.
I am seeing caution by the CEO. Some can call it hiding, however after we heard about the failed premature grant submitted in collaboration with GMU, I think that was a sign to be prepared. Just cause you have what might be a Covid miracle drug doesn't mean the FDA/NIH/Barda are going to support you
I think Leo was prepared, and have heard supporting comments to this effect, to start trials this Q. It seems every blue moon someone on this board has info about delays. Recently I read about RBL internal delays that were unknown to me (and I am sure most everyone else here). It could be a lie, but it could also be true. We just don't know
I assume someone will come out after the trial starts and say the company had to overcome logistical delays... whether it was wrong paperwork or just blame it on the holiday schedule (which some of us were cautious about in Oct/Nov to begin with)
There will be a trial. There will be interim results. I believe we need to have greater results then Remdesivir first displayed
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
and my inlaws (in their 80s) recently contracted a mild case of the virus. Right now the regiment down here in Palm Beach county seems to be give 5 days of Remdesivir, add in convalescent plasma and throw in some steroid. In and out of the hospital within a week (again, mild case). Can't say what is given to more severe cases.
over the years i have invested in bio/pharma companies involved in clinical studies. Other than knowing about moderate to severe hospitalized patients, we don't have much else to go on. Years back i was in PTI and which was up against bigpharma. When PTI's drug was given to virgin patients never receiving any other medication, the results were statistically significant. Had the patient been given prior medication by it's competitor, the results were found not statistically significant.
I know the RBL in vitro has said the synergy of the 2, remdesivir and brilacidin, basically make the virus go away 100%.... however we are not informed yet how B works in humans for C, let alone along side R.
Leo doubled down on Nov 16th
Prior to the IND being submitted he was still calling for trials to start before the end of year.
Even us armchair QB players can read that the FDA will hold an IND for 30 days before it becomes active if FDA has no issues with it. There was no condition in the PR that said 'upon expedited IND approval'
The above being said, on Nov 16th, Leo doubled down by acknowledging within the last 2 weeks of the year we would have an active IND and trial enrollment would begin within the following 2 weeks.
There is no way for us to extrapolate where the CTA was submitted and how long that application process takes. The Russia "rumor" was quickly shot down by the "supposed" source
http://www.ipharminc.com/press-release/2020/11/15/innovation-pharmaceuticals-announces-overseas-regulatory-filing-submitted-for-covid-19-clinical-study
it isn't the 2 liter type
It's an expression of a stock going parabolic
if you prefer, the stock might go parabolic, not moass, if enough flippers/momo players show up to the party
The float as of Nov 30th is 300,000,000
Rough/quick math: 300,000,000 x .20 = $60,000,000
Given the hysteria in today's market of chasing any stock with positive relative strength/momo/etc.... that trade dollar value is quite attainable in a day. Just look at ocugen volume a few days back. i am not comparing the s/s, however i am saying there is ridiculous money waiting on the sidelines to go for multi baggers in a short time frame
i agree once the human trial news starts flowing, assuming it's positive, the market cap won't matter. momo players finding out there is a penny stock starting human trials should do the trick to get us over a buck (and higher if there is moass)
I'll feel better when I see something
here: https://www.clinicaltrials.gov/ct2/home
A sponsor is allowed to post their study before recruitment begins and since we have an approved IND, we can call our study 'active, not recruiting'
or here: https://www.clinicaltrialsregister.eu/ctr-search/search?query=covid-19
I don't know why there is a tit for tat mentality here. Why don't we all try to work together instead of raising drama
I'm in partial agreement with you
I will only comment as it relates to Covid and Ipix.... anything prior to that really isn't of interest to me
Posters have commented that the RBL slowed us down and that's why it took so long to get here. I disagree with that statement. IMHO if it were not for the RBL, IPIX would not have pursued Brilacidin for Covid. The early on IPIX Covid PR's spell this out.
I think IPIX was a reluctant passenger on the covid journey until the liquidity came back to this stock and this is where I partially agree with you about dilution. The reality is IPIX had next to no cash and a PPS headed toward sub-penny and the need for millions for any study.
The addition of degrado to the company was to lead the B for C studies leaving the ceo time to do other things
I disagree with you because the B for C study is not a scam. I am cautious of when this trial will start and would love to see a real clarifying PR. Something happened after Nov 16th to cause the company to drop the commencement date or timeframe from the PRs.
The key here is for the P2 trial to begin
Nov 2nd and Nov 16th IPIX said on track for Q4 start date
Language regarding a start date whatsoever disappeared from the Nov 30th and Dec 21st PRs.
Question is now that we have an active IND, and all the preparation the company said to have done now expediting trial enrollment, what is the new target start date?
IMHO once we get a first dosing PR we can push through the most recent financing deal and everyone will be jumping onboard to catch the next covid play multi bagger.
GLTA