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Is this the peep you were looking for? From page 9 of the K
Business Development and Licensing
The Company is actively engaged in business development and licensing initiatives with multiple specialty and global pharmaceutical companies. From time to time, the Company may be party to various indications of interest and term sheets and participate in preliminary discussions and negotiations regarding potential licensing or partnership arrangements. It remains the Company’s primary objective to complete licensing deals, territorial and/or global, to provide access to non-dilutive capital to advance clinical assets forward in the most expeditious and cost-effective manner. The Company can make no assurance that partnerships will occur, but is committed toward executing on these potential alliance and partnership opportunities.
Because the DMC was reviewing the previous interim data again to make sure? ...or a different group of experts from another DMC were doing so?
The FDA needs such safety data before they authorize compassionate use.
"What is a data monitoring committee (DMC)? The FDA defines a data monitoring committee as “a group of individuals with pertinent expertise that reviews, on a regular basis, accumulating data from one or more ongoing clinical trials."
https://www.google.com/search?client=firefox-b-1-d&q=FDA+and+DMC
So almost two years ago Menon and the company disputed Menon's invoices...any evidence that Menon has taken the company to court yet?
You bet, excellent K... let er rip! AND...
News of compassionate use will travel fast in this environment.
This is a big fat positive, and was likely instrumental in getting the FDA to approve compassionate use of Brilacidin for Covid-19 patients in the hospital... Those "critically ill" patients who are beyond the severity of those dosed in the clinical trial.
The election is over, and businesses often wait until the uncertainty is over... so get delta cases down some more and new shops should be popping up as life returns to normal
Wow, looks like a phase III trial for Brilacidin Oral Mucositis is coming in Q1 of 2022. CEO is NOT resting on his laurels.
So where the heck are all those shares that keep blocking the ask coming from, if IPIX has not sold shares to Aspire since 9-14-20?
I Haven't had time to parse the 10K. How did Leo manage to accrue over 11 million in company coffers at the time of this filing?
From the 10-K
"Coronavirus Treatment Acceleration Program
FDA has created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP). The FDA website describes the program as one that “uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.” Subject to FDA approval, the Company plans to utilize this program."
A clear path to approval if PH II results are good.
More or other news could drop at any time. This 3-5 week window before top line results could be padded for a reason
Current price has little to do with what may be coming here
Comparing IPIX Market Cap with its competitors. IPIX is WAY UNDERVALUED IMO
CYDY-
Shares Outstanding- 644 Million
Market Cap- 1.58 Billion
Share Price- 2.32
RLFTF-
Shares Outstanding-3.4 Billion
Market Cap- 516 Million
Share Price- 0.145
IPIX-
Shares Outstanding-426 Million
Market Cap- 117 Million
Share Price- 0.232
NWBO-
Shares Outstanding- 879 Million
Market Cap- 1.27 Billion
Share Price- 1.44
As of Sept. 23, 2021
FDA has approved Compassionate Use of Brilacidin
September 23, 2021
In related news, the Company has received individual patient Expanded Access (compassionate use) requests for Brilacidin to treat critically ill COVID-19 patients who are not responding to prior therapy. Expanded Access was implemented by the FDA and Congress to address physician applications for access to potentially lifesaving drugs, prior to FDA approval, for patients in their care when available treatment options have failed. Following receipt of such requests, the Company has supplied Brilacidin to relevant hospitals for individual patient use, with the FDA granting the treating physician permission for the emergency administration of Brilacidin. In addition to Brilacidin’s antiviral profile, Brilacidin’s immunomodulatory and anti-inflammatory properties may be particularly beneficial in treating COVID-19 in hospitalized patients.
https://www.ipharminc.com/press-release/2021/9/23/innovation-pharmaceuticals-provides-update-on-covid-19-clinical-trial-compassionate-use-requests-and-research-into-brilacidins-broad-spectrum-antiviral-properties
Comparing IPIX Market Cap with its competitors:
CYDY-
Shares Outstanding- 644 Million
Market Cap- 1.58 Billion
Share Price- 2.32
RLFTF-
Shares Outstanding-3.4 Billion
Market Cap- 516 Million
Share Price- 0.145
IPIX-
Shares Outstanding-426 Million
Market Cap- 117 Million
Share Price- 0.232
NWBO-
Shares Outstanding- 879 Million
Market Cap- 1.27 Billion
Share Price- 1.44
As of Sept. 23, 2021
I suspect media outlets are catching a whiff of this compassionate use news, and will be all over it soon.
Doctors and patients would not be asking for Brilacidin in a vacuum of knowledge about its potential benefits. As the saying goes, "someone knows something."
Plus, the FDA would not allow compassionate use if Brilacidin had not already proven its safety.
Add those two together and we may have the golden duo: a therapeutic that is safe and effective. We'll have to wait for top line results in October for validation of this.
How much is a good therapeutic worth?
We know there is no viable therapeutic for C-19 at the present time.
That may have already happened, or we're about to find out.
I agree, the Real World is what matters, and now we have a reasonable time frame for top line results, mid to late October is 3-5 weeks away!
Today lit the fuse... and with the FDA now involved approving Brilacidin for compassionate use, I'm convinced the SP will blow the F up at some unexpected moment in the next 3 weeks.
Yes, plural... Brilacidin sent to more than one hospital for compassionate use.
FDA involved with approving Compassionate Use for Brilacidin. Wow, I agree EUA may not be far behind after trial results, IMO
Let us know when George Mason RBL gets worried, or the US military who knows of the potential of B?
Actually the military is worried about future pandemics, and Gilead is worried about their Rem drug.
A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
CEO Ehrlich saw what happened to other small companies that did not stay silent until news was ready.
He's smart to play it safe. Brilacidin has never failed a clinical trial
Here comes the turn, it's an old pattern on this "marketplace"
Many are still buying at these levels, including me
September 17, 2021 07:29 AM EDTUpdated 08:17 AM Coronavirus
European study finds that Gilead's Covid-19 antiviral remdesivir shows no clinical benefit
Nicole DeFeudis
Editor
Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.
https://endpts.com/european-study-finds-that-gileads-covid-19-antiviral-remdesivir-shows-no-clinical-benefit/
The large bid has moved up to .28 and may need to slap the ask before the close today if wanting in. No telling what news might come next.
Bids are building going into the close. Data lock next week is a reasonable assumption.
4 Very important positive indicators and one could add #5 with Gilead.
#3,4, and 5 all have check books in their pocket, watching and waiting.
If there's an end of day volume surge, the MMs could lose control of the ask.
CDEL keeps beefing up the ask... yawn... I'm waiting for news to bring in real volume.
Big moves UP can start with a trickle, but I know what you mean. Longs have been conditioned to these "classic" maneuvers.
Then again, news IS pending.
We're close... very close
The question now is whether Leo will PR the data lock first, or carpet bomb the shorts with stellar results out of the blue? Fingers crossed.
Here's to the clinical results matching in vitro results!
I guess the MMs finished doing their laundry for now?
The CEO is being careful not to hype. He doesn't want the company to be negatively "sanctioned" by the FDA the way CY*Y was.
I don't think the issue is censorship, per se.
Instead we're waiting for being "sanctioned" in the positive sense, i.e. forms of approval, including the possibility of Emergency Use Authorization (EUA) for Brilacidin.
Funny how the same word (sanctioned) can have opposite meanings, depending on use and context.
Nice stair step UP, is this the turn?
And just to make sure, the MM GTSM puts up a big block to scare off buyers, wanting to give the impression there are lots of sellers?
LOL RESULTS COMING ANY DAY NOW.... NOBODY SELLING EXCEPT LAUNDRY MAKERS!
Well, the MMs need to close it below .24 which was yesterday.
It's just what they do... until buy volume overwhelms on good results.
Lots to coordinate with this international trial. Lots of ps and qs to attend to.
Hang in there, shouldn't be long now
Good explanation for recent playbook: