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As a pro trader, is 6 million a lot of money? Oh, no! Where will lil IPIX ever get alllll those millions?
Aspire isn’t the last resource, it’s one of the first with very favorable terms. Pros know this. What’s more Leo still hasn’t tapped all those other sources of funding.
Moreover calling a partner or licensee a “white night” is a misrepresentation. It’s what the company has worked toward for 7 years and has been the basis of the business plan the entire time. Its been in every 10k the entire time. It’s the foundation for all biopharmas’ business plans, both public and private. Your posts twist it into something out of desperation. It’s not ALL biopharmas license or partner their drugs.
Read the thread again and more carefully. Or, don’t, and continue missing the point.
Oh, bullshit. Financials don’t lie but people misrepresent them and what they mean.
And then the price evidence turned green. Go figure.
Let’s go back to the original statement I agreed with, “The agendas here are quite clear, they want your shares, that simple.” Yes, naming those with agendas would be a TOS violation.
Do you want names? That’s a violation of TOS. But I can say many of “they” represent hedge funds and small cap biopharma specialist interest. This isn’t conspiracy theory; this nothing more than “follow the money.”
An interesting question coming from a post rated as pro. “Again who are they? Why would ‘they’ want ipix shares that go down day after day, for years?”
I agree completely, with the exception that one or two agendas are just some kind of grudge thing with an irrational fixation.
That wasn’t the point of the post IMO. A number of investor-traders are accumulating at the bid. When the bid drops they continue to accumulate. Proof? Look at how few trades it took to move from .5 to .52 at the end of the day and compare that to the sell volume that took the sp down to .5. Low volume drop that can’t penetrate 50 cents? Higher next week...
What nonsense. All time low is .10. We are still 5 times that.
It does if the decline is with low volume.
Kevetrin modulates p53. This is now proven. That’s what a p53 drug does. That’s it’s efficacy.
K is effective, dammit. It modulates p53, as it’s supposed to. Whether or not it works as a stand alone is yet to be seen, but in cancer therapies, there are few stand alone drugs. The cancer arena is dominated by combined therapies including surgery and radiation. K will become a vital part of drug combinations. Fact is it does what p53 drugs are supposed to do, it does what many of sought to do for more than 20 years, safely.
Repost with corrections: Trial failure
Inability to meet any primary outcome:
Phase 1 and 2 trials one of the primary outcomes is always safety. Failure to meet agreed upon safety measures always leads to trial failure with a possibility of redesign and repeat the level of trial once safety issues are addressed. A good example of this was Brilacidin ABSSSI Phase 2a where there were two safety issues cited. The doses were lowered and the escalation trial redesigned as a Phase 2b. The FDA approved the 2b as having addressed safety concerns.
Phase 3 trials generally fail with efficacy as a primary outcome. A drug can fail as noninferior to a standard of care, that is it is less effective than the current standard. It can also fail as being as effective but has more risk of side effects with little or no benefit over the current standard. Or, of course, it can fail if the final data has little or no improvement over a placebo.
However, one should note that "safety" is rather a squirrelly notion, one that shifts with the mortality of the disease or condition and the toxicity and reactions to the drug when administered. Cancer drugs might have rare side effects that can lead to death, yet may still be considered acceptable against the mortality rate of a particular cancer with few or no treatment options. An antibiotic, on the other hand, with plenty of options, might fail due to something as simple as elevated blood pressure and rare cases of kidney damage.
It's seldom that a trial fails when secondary outcomes are not met, except when they are safety outcomes for late stage trials. Vaccines often fail for this reason. A dengue vaccine, a few years back, failed after administration of 25000 doses in a Phase 3 trial. Seems some of the vials had attenuated dengue strains that reverted to wild type. I believe there were 5 doses administered that gave subjects dengue who subsequently died.
Trial failure
Inability to meet any primary outcome:
Phase 1 and 2 trials one of the primary outcomes is always safety. Failure to meet agreed upon safety measures always leads to trial failure with a possibility of redesign and repeat the level of trial once safety issues are addressed. A good example of this was Brilacidin ABSSSI Phase 1 where there were two safety issues cited. The doses were lowered and the escalation trial redesigned as a Phase 2b.
However, one should note that "safety" is rather a squirrelly notion, one that shifts with mortality of the disease or condition and the toxicity and reactions to the drug when administered. Cancer drugs might have rare side effects that can lead to death, yet may still be considered acceptable against he mortality rate of a particular cancer with few or no treatment options. An antibiotic, on the other hand, with plenty of options, might fail due to something as simple as elevated blood pressure and rare cases of kidney damage.
It's seldom that a trial fails when secondary outcomes are not met, except when they are safety outcomes for late stage trials. Vaccines often fail for this reason. A dengue vaccine, a few years back, failed after administration of 25000 doses in a Phase 3 trial. Seems some of the vaccines, I believe 5 doses that were administered, gave subjects dengue who subsequently died.
Can you provide where the company actually said this?
“K needs a pill. We had to abandon our 2A because the dosing was inadequate and cash is tight. We even had to lay people off and cut Menon's pay.”
Ironically, this quote is in the same post where you mention people going overboard. I’ll apologize if you post where the above was stated.
You’re the one who was saying somebody knows something. Well, this PR refuted that nonsense. So, it’s not “fluff.”
Oh, bullshit. The science isn’t stalled; it’s moving forward. It can’t be trial following trial. Data collection, evaluation, next trial design, FDA feedback, etc are all part of the progress and take time. That’s where we are currently on all 3 fronts. Soon enough there will be a deal, once P data is in and evaluated.
Science isn’t stalled. It continues to move forward. They are now working on:
Oral reformulation for K and the bridge study
Formulation for B OM to increase exposure of mucus tissues
Formulation for UP foam and delivery as a foam
Prurisol final data collection and afterward Phase 3 design
All of this is currently moving forward. None of the above is waiting for a partner or license.
Nothing like making things up. Share price is disconnected from IP value at this point. There are just too many ways left to raise funds for the next trials, which managent is in the process of designing and proposing. The technology is not frozen, it continues to progress whether it’s visible to outsiders or not.
As we speak, IPIX is designing a bridge study for oral K, a study very much in methodology of Prurisol’s bridge study. That isn’t “in the shed.” That’s active development. For the most part, bridge studies are cheap and fast.
K didn’t fail. It met all endpoints and outcomes for the trial design. Now IPIX is working on a bridge study for the oral formulation. If K failed, they wouldn’t be doing that. It would have been shelved until the first upfront payment.
I’m not “praying for Prurisol.” Prurisol is a bonus to Brilacidin’s successes in OM, UP and ABSSSI. Moreover, OM failure or “weak performance” is a fiction. Brilacidin is poised to bring in half-a-billion to a billion over the next 5 years in combined upfront and milestones.
First of all, bankruptcy requires debt that can’t be met. IPIX has very little debt, and most of that is to officers. Secondly, there are lots of avenues still open to move B forward regardless of what Prurisol does. Third, Prurisol is not going to fail. Next month the only question remaining will be which to license first, P or B. Finally, if one shuts out all the negative chatter and looks at preclinical and clinical data, there is already enough evidence for a lucrative license or partnership for any one of 4 disease indications, and more than enough to partner an entire platform for 100s of millions, maybe a billion or two.
Sure get tired of the bullshit spread on this thread. You’d think this forum was preparing rice paddies.
All of the buzz words and none of the data points. Or another way to put it, all hat and no horse.
“try selling on the .59 ask.”
That doesn’t even make sense. The ask is someone trying to sell at .59.
Leo said last week it was on schedule for the end of the first quarter.
The rest of what data? Can you be specific? Someone with lots of experience in biopharmas should be able to easily identify omitted data.
The plan for K has always been to get a full characterization. While there was hope that it might work as a stand alone drug, Menon’s strategy was and is to use it in combination with other drugs to enhance their efficacy and extend periods of remission. K may yet work alone against a few resistant or types of cancers with compromised p53, but there is still much work to do through extending systemic exposure as well as more testing in combination. As for an effective drug that repairs and modulates p53, it has been very effective with promising evidence of tumor growth arrest and reduction.
If you mean the company, they haven’t used quiet period at all. If you mean posters to iHub then it’s only been suggested as possible during lengthy periods of no news. This time there is good reason to think it’s a quiet period since last we heard from Leo IPIX was working closely with some big pharmas.
“They are moving forward with a K pill and drafting a proposal to the FDA for both a bridge study..”
The quote is public information. Leo reported the above to investors. The rest is Investment 101 and untapped sources for funding not yet used by Leo.
Of course it’s not inside information. These are four untapped options for funding. This is investing 101, know the corporate funding options.
K isn’t idle. They are moving forward with a K pill and drafting a proposal to the FDA for both a bridge study and and the next phase study once the bridge study establishes it's essentially the same drug in both MOA and safety.
Plan A is partnership or license, Plan B is PIPE (I’m in if it comes to that), Plan C is sell something, Plan D is hit the VCs.....
One shouldn't confuse relief with happiness or elation.
Again, the outcomes were written broadly enough that 2 or 10, outcomes were met. We are talking changes due to Kevetrin, in particular those changes related to MOA. The question is whether or not 2 patients is sufficient to assess MOA. I would not claim either way, yet some have proclaimed the Kevetrin trial a failure without actually knowing what assays were performed, the reliability of those assays, nor what the assays showed.
Thanks for that source. I don’t recall anyone providing the link. Guess I missed that.
Can you provide a link to “2 patients”? Granted, I may have missed it, but I have only read that number from posters here and not from IPIX or Leo.
The outcomes were primarily to gather more data on all measures and to better characterize MOA. For all outcomes endpoints were met and outcomes achieved. Please note the trial design did not include efficacy measures regarding direct apoptosis, rather measures applied to p53 repair and modulation as efficacy. Mistaking p53 efficacy for tumor reduction as the only meaningful efficacy outcome is very common misperception in the ongoing discussions here.
Yes, met all outcomes including MEASURING tumor response and RECIST data. Don’t need you to read secondary outcomes since I have read them several times, unless you want to and I can point out what they say as opposed to what many think they say.