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Same goes for IPIX!
IPIX Data Lock any day now...Welcome to September IPIX!!
Pressure will be on FDA once they launch international VLN, but I think we get MRTP before then.
More than NZ will be interested, although they will be the first country to adopt.
Well thought out post and entirely feasible.
After B-COVID'S "presumably" stellar P-2 results: What next?
Link back for CMC's logic
good point about Gilead's declining revenue. IMO there will be others at that table. Could turn into high stakes poker for B licensing and/or partnerships.
The MHSRS abstract will likely be part of the next press release by the company. I wouldn't be surprised if it comes out tomorrow, but I would think sometime this coming week.
I hope they don't have to resort to that either Pete.
If results are good enough to get EUA, then IPIX can "go it alone" and will be able to raise cash inexpensively, plus they'll likely receive non-dilutive funding from various sources (gov., military, NIH grants, etc.)
If no EUA, but still good enough to get everyone's attention, then IPIX will need to license or partner for a PH 3, depending on where share price goes.
Europe, Asia and South America could be on the phone with Leo right after PH 2. How to scale up production to meet demand will be another issue for IPIX, given good results and immediate interest in B.
Everyone knows in vitro is not the same as in vivo, but I like the odds and have loaded up.
Thanks for framing VLN accurately. It's simple enough to understand that almost anyone in kindergarten could get it. Almost...
I suspect Leo has already had "conversations" with Gilead. The synergistic effects of B and R drugs in vitro were fairly stunning.
For all anyone knows, Gilead could already have various offers on the table, waiting for PH 2 clinical trial results that might meet or exceed R.
I hope people remember that Leo established an Irish subsidiary a couple years ago:
"Innovation Pharmaceuticals established the subsidiary as part of its commitment to expand development its clinical pipeline—including Brilacidin, its Host Defense Protein-mimetic drug candidate with multiple therapeutic applications..."
http://www.ipharminc.com/press-release/2019/2/26/innovation-pharmaceuticals-forms-irish-subsidiary-to-facilitate-international-development-of-clinical-pipeline
You may not recall that the vast majority of shareholders voted to double the authorized shares at the last shareholder meeting. I believe it was over 90% "yes" for that authorization.
Which tells me shareholders have confidence in the CEO to dilute as necessary... and by comparison with other OTC bios, he has been very frugal.
Most have followed the science for many years, and the rabbit's ears now appear visible at the top of the hat. It won't take a magic trick.
Fast Track Designation from the FDA this past January is one example, and others are easy to find.
About 30 minutes left of trading in July. Next week?
Don't know when but,
Data lock coming,
Military abstract likely coming,
Trial results coming,
And... Leo has surprised with unexpected positive news before, too.
Some recent Pro and Con Arguments:
Pro:
Brilacidin has never failed a clinical trial
George Mason University’s Regional BioLab testing confirms stellar in vitro results of Brilacidin for Covid-19 and several other viruses
Company received Fast Track Designation from FDA
Phase 2 International Trial results expected in August-September
Brilacidin has shown three (3) MOAs to combat Covid and its sequelae, and has a selectivity index of 426
Company had 14 million in the bank as of end of Feb. 2021
Company has given a presentation on new in vitro data to the American Society of Virology just days ago.
The share price has risen dramatically this week on higher than average volume.
Con:
Leo hasn’t updated any other Brilacidin indications
Many Phase 2 trials but not one phase 3
Don't underestimate the level of stupidity (in the CEO)
Leo has neglected shareholder communications
Leo is diluting for his own “lifestyle reasons”
It's B for Covid or bust.
This company is a scam just like all the other pink sheet stocks
It used to be that multiple perspectives and news sources were weighed side by side and critiqued for evidence and logic. Back then it was called critical thinking. Today people don't even believe the epidemiological numbers coming from vaxed and unvaxed people.
IPIX in vitro results have been vetted by RBLs, among them GMU, a prestigious institute. The results have been peer reviwed. Disrupting the viral envelope is huge. Having 3 MOAs is even better. I realize you know all this, but some do not.
Just as some may not realize there are doctors practicing medicine who don't know the definition of peripheral neuropathy.
Good luck to you and all longs.
That seems close to a semantic argument about the military conference and their 'interest', unless they've never heard of, nor are interested in Brilacidin's potential anti-viral uses for Covid-19, which are pending.
Everyone can read the specific title and focus, but viral indications are interconnected, given the GMU in vitro results. Plus IPIX would not have said their PH 2 trial results would be available when the conference accepted the company's presentation and scheduled it.
At the very least this will alert the military to pending trial results for C-19, as well as potential uses for Non-SARS-CoV-2 Endemic Viral Diseases.
MMs very alert to drop it down at 3:59:59 the last two days, and on piddly shares.
The silver lining is the RSI gets cooled off, so IPIX is ready for the next leg up.
Not quite as dire as all that... yes, Russia is selling a generic version of remdesivir to India, but part of the reason is the much lower cost than Gilead charges. Of course, Russia claims humanitarian reasons for delivery but they also score geopolitical points with India for selling to them inexpensively.
https://www.reuters.com/world/india/russia-ships-remdesivir-drug-india-part-humanitarian-aid-2021-05-25/
Even if B were to be made generically and sold at a fraction of 1st world prices, the income would still be substantial for IPIX when balanced by legitimate licensing deals and possible military needs.
A few well-known IPIX competitors on the OTC ran to between 1-2 Billion market caps last year.
With decent upcoming results IPIX should at least match those MCs.
Add the possibility of EUA, military interest, licensing, partnership for PH 3, and multiple indications for Brilacidin...
and all bets are off where this could go.
All IMO of course.
One of the best posts about IPIX this month, and arguments about spell-check technology snafus don't wash.
Click back for good information from Billy10us
means we should go higher... volume and call options will indicate when MRTP is imminent.
Dunn, the FDA told Leo no advertising, no boasting until trial results, then the money starts to flow with good results.
Why would anyone want to compromise the trial or piss off the FDA?
Rhetorical question
Maybe a little bit of frontloading before more Canada franchise news comes out?
And the walls keeping tumbling down!
Anyone watching level 2 can see the block and tackle efforts of naughty knight and crafty citadel, especially end of day. Or actually any other time they're about to lose control of the ask.
But not for long...
Only until buying pressure overwhelms (good trial results). Why not start to unwind now and take it up slowly over the next weeks?
The MMs are taking it up slowly before trial results.
100M market cap now...lol
Overnight 10X with decent results, minimum IMO.
The vir and mab drug makers are watching this one closely
GATEWAY INDICATION has a nice ring to it.
Great summary, thanks!
And goosing down should be reserved for the inside of pillows, lol.
It's the pot calling the kettle black
Archiving all the negative CEO talk should prove to be fun reading in a few weeks, if B's results are as good as many believe they will be.
Your whole post is excellent and longs I know agree. Brilacidin is a platform drug with many indications. Different BPs will be interested in different indications. Covid variants come first and results are pending.
Let's not forget that besides Covid viruses, Brilacidin also has UC and Colitis indications being watched by BP
Zero "employees" needed for licensing and/or partnership
Relax... RSI touched 70 and pulled back. Big deal... The science hasn't changed, but the noise sure has increased!
Time for XXII's VLN alternative to shine. Once MRTP happens, BT and BP will be scrambling to buddy up with cash, if not a buyout IMO.
It's called distraction...or perhaps boredom until top line results.
As in distraction from the SP inching up in anticipation of a successful PH 2 clinical trial, with Brilacidin quite possibly one of the only viable therapeutics to combat Covid variants, as well as other viruses, since one of its MOAs is popping viral envelopes.
One explanation is agility. Leo can license, partner or sell with the right terms. Please remember to include the following propaganda items as part of Leo's "lies" (lol):
Brilacidin has never failed a clinical trial
George Mason University’s Regional BioLab testing confirms stellar in vitro results of Brilacidin for Covid-19 and several other viruses
Received Fast Track Designation from FDA
Phase 2 International Trial results expected in August, 2021
Brilacidin has shown three (3) MOAs to destroy Covid and has a selectivity index of 426
Company has millions in the bank
Company will be giving separate presentations to the American Society of Virology in July, and to the US Dept. of Defense in August
Thanks for this info, it will be interesting to see if he shows up again to comment on the company and it's progress, or to whine more. I would doubt it though, now that he's been paid off. If he has residual shares, let him dump at .15
What with LFER having SmartAxiom as a wholly owned subsidiary, their important patents, and likely Woloshin and Abrams helping navigate a bit in the background, plus continued cleaning up mistakes from the past, this baby is getting ready to roll.
Ween yourself off nicotine addiction with VLN. The research is there and institutional buying of XXII over the last year agrees.
MRTP comes first and then perhaps very low, non-addictive levels of nicotine gets mandated.
Maybe both policies will be implemented at the same time.
Many of the negative arguments (2 person shop; insufficient BOD, etc.) actually make it easier for Leo to license or sell B indications, if he gets his price.
Unless he gets a big Gov. grant or starts selling purchase orders to India, Brazil and Russia, I doubt Leo will want to begin beefing up the company to compete with established pharmas.
Positive Brilacidin PH 2 results will give him many options.