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A partnership or license isn’t a surprise? That’s a surprise to me.
What you keep posting assumes uses that are theoretical and have little to no evidence of efficacy in even animals because 1) Prurisol will likely require reformulation even if the current form does show promise; 2) Abacavir and the current salt of abacavir was formulated against psoriasis and not other inflammatory diseases like arthritis; and 3) assumes things not even publicly discussed as uses and plans by IPIX scientists.
While there is an argument that Prurisol currently has a valuation ranging from 500 to 1000 million at the current stage, $10 billion to nearly everyone is premature, considered highly excessive, and an attempt to pump the price, all of which result in exactly the opposite of the post’s and valuation’s intent.
Correct. There is no way a large pivotal study could be done in one year much less receive approval. Even with an agreement the NDA takes 6 to 9 months. It would still be at least one more year for approval for ABSSSI with no other drug advancement.
What nonsense! This last Aspire deal doesn’t “lead to a partnership.” No one thinks that. It strengthens the position of IPIX when negotiating partnership(s) that are already in the works through CDAs. The 30 million in available funds provides a source of financing for the next round of trials.
What bullshit. The 3 current trials are for 3 drugs each of which is more valuable than ABSSSI. Two of those trials, OM and UP, further the understanding of Brilacidin and confirm it’s anti-inflammatory characteristics. Also, focusing only on ABSSSI and striking a deal only for that would have allowed a BP to exploit off-label use after approval causing a loss of value and compensation for other bacterial infections against which it would be effective.
The right choice was 3 trials in phase 2 where 2 of those trials further demonstrate the full value of Brilacidin.
Not at all true. The consensus was that the entire B platform was then worth billions, but based on the antibiotic deals struck during those years that same consensus was from a half billion to a billion for ABSSSI.
trying to sell some here but they won't allow it
What you keep posting assumes uses that are theoretical and have little to no evidence of efficacy in even animals because 1) Prurisol will likely require reformulation even if the current form does show promise; 2) Abacavir and the current salt of abacavir was formulated against psoriasis and not other inflammatory diseases like arthritis; and 3) assumes things not even publicly discussed as uses and plans by IPIX scientists.
While there is an argument that Prurisol currently has a valuation ranging from 500 to 1000 million at the current stage, $10 billion to nearly everyone is premature, considered highly excessive and an attempt to pump the price, all of which result in exactly the opposite of the post’s and valuation’s intent.
We don’t need approval in 2017 or 2018 to become a revenue generating company. Leo has stated again and again that they are looking for a partnership. A partnership/license for Brilacidin OM will bring in at least $50 million cash with at least 500 million in milestones. Prurisol will bring in something similar. After the first FDA approval, with multiple partnerships across all three platforms, over the next 2 years, I’m anticipating a BP buyout.
It’s both. Those weren’t free shares because he legally claimed co-invention based on the use of CRO work in the patent application. As a CRO he wasn’t entitled to more than a small ownership share, but in the absence of that boilerplate clause outlining that the work, should it be included in the patent application, did not entitle him to more than the contracted payment. Under patent law, all inventors, no matter how small their contribution, must be listed. In the application, there are separate lines for inventors and assigned owners. Not including Aruda as a co-inventor gave him rights to co-invention and ownership in the absence of stipulation otherwise. Aruda and his attorney knew this and threatened to put the patent in jeapardy and tie it up for years.
False. IMO Aruda was a development CRO who gained part inventorship because the CEO at the time effed-up the research contract with Aruda's company. CROs rarely receive more than a few percent from ownership rights, if any percentage. Menon paid a heavy penalty because of the idiot in charge at the time, an idiot who also ran CTIX into a ditch before he was replaced by Leo.
Nothing in your post is correct:
Prurisol was not a failure. It has been proven safe and the current trial has both a safety outcome at higher doses as well as dosing at up to double the Phase 2a trial.
The current K trial is powered for characterization and OC was chosen because there were strong efficacy signals in the Phase 1trial. They added sites after clear safety at higher dose frequency and slower than expected enrollment.
Arudas did not get 15 million free shares. They received 15 million shares as co-inventor of the Kevetrin formulations. They received them from Dr Menon, not IPIX.
Nothing in your post is true other than there is a P and a K.
He has the ability, money and sources to run 2 phase 3 trials. B-OM and B-UP won't be as expensive as you think. As he has up to now, he can outsource the trials to a CRO. That's what they do.
Correction: effective yesterday, 9/21/2017.
Important notice because it now insures the ability to raise funding for Phase 3 trials should BP lowball in negotiations.
"KEVETRIN CAN LEAD TO A GROUNDBREAKING MOMENT IN THE WORLD OF ONCOLOGY AND IS A VITAL KEY TO THE NEXT GENERATION OF CHEMOTHERAPY.”
— Dr. Emil Frei III
Yes, that's pretty guarded when compared to "[he] would be very pleased with the progress today".
No, what?
8 trials, 5 completed and no failures. What does any talk of failure have to do with IPIX? Oh, failure to uplist, as if that was some how critically important and would have stopped the Mako attack. What complete bullshit.
Efficacy for Kevetrin is p53 activation. The current OC trial is to fully characterize its MoA to best match it with current therapies. Saying it's not effective completely ignores its MoA and purpose. While there is hope that it will effectively shrink tumors as a monotherapy, that is not what Kevetrin and the p53 Holy Grail is all about.
That is 100% false. Kevetrin is proven effective as its primary purpose is to activate and modulate p53. IPIX proved that in the Phase 1 trial.
K efficacy is yet to be shown or proven - so lets wait and see.
Do any in that crowd activate and modulate p53? There'll be a lot of room for Kevetrin after approval as part of a combo therapy.
Wait a couple of more days, there will be plenty of liquidity for that nickel flip.
you just can't sell
Untradable? I added more yesterday and will add more in a day or two when my latest funds clear.
Whether one holds a few seconds for a high-frequency flip, from morning to afternoon as a day trade, or from January 2014 to present, the purchase of shares is an investment upon which one hopes to make dollars in the latter case or golden pennies in the first.
Only a non-investor would not know this.
Sofinnova is a venture capital group that buys equity in biotechs = shareholder dilution.
Grail, Inc is privately held whose founder and head started the company after his wife died of cancer.
Guardant is a privately held company.
Entasis Therapeutics is also privately held.
Rapid Micro Biosystems is another privately held company.
So, all your applicable examples are privately held corporations Got anything else that's actually relevant to IPIX and public corporations? Public corporations tend to get pounded by dilution and discounts when funding through VC equity positions.
Can you give an example or two of ownership deals with a percentage stake? Wouldn't that still be market-price-based ownership and dilutive? Doesn't such a deal usually include one or two board members plus increased risk of a hostile takeover?
IPIX investment should not be done using money needed for other things like house payments, electric bills and baby formula. If someone is using money for biopharma investing instead of paying bills and eating, then that person is doing his/her investing completely wrong.
Only problem is, you can't eat or pay your bills, with 'hope'.
While I thought it might be otherwise, I now agree with you. It's most likely normal over enrollment due to 34 clinical sites.
Speculation and nonsense. There is no evidence supporting this. I don't know the reason for scrapping interim data, but if we are going to speculate it makes more sense that BP either asked for no interim release or there was a possibility that interim data might lead to speculation of study bias. This is especially true since the highest administered dose comes at the end Prurisol demonstrated increasing efficacy with increased dose.
Also, Phase 1 was a bridge study with no efficacy metric, which weakens that already very speculative argument.
They saw more potential from pre-clinical study than P1 P2 - that tells the difference.
It's not guess work. The next study proposal is for healthy volunteers because of no cytotoxicity. That's a bridge study. Otherwise it would be another phase 1 with stage 4 cancer and no hope.
The fuller characterization of Kevetrin from the OC Phase 2 will likely allow a bridge study to show the oral is sufficiently similar to the injected. Your post implies, and you've stated before, that it's back to square one, and that's not the case. With healthy volunteers it will be a fast escalation trial. Once done and demonstrated, then they will advance to combination therapies, or even Phase 2b trials for OC should the current trial show tumor arrest and reduction.
If you are really truly ready to ink a deal you demonstrate sources to go it alone, the ability to fund the next rounds of trials. No sources of funds is a great way to get low-balled by BP.
Aspire loans? Is that through the IPIX sales department?
Correct, and most useful after these most recent Phase 2 trials expand understanding as well as the broad spectrum use for both antibiotic and anti-inflammatory. A much fuller valuation will be evident once partnerships are struck.
The ABSSI phase 2b was not a mistake at all. It was fast and relatively inexpensive contrary to what you claimed. It helped proved that Brilacidin is a very potent antibiotics superior to most antibiotics available on the market. These results will be quite useful for several applications of Brilacidin in the future.
No, not necessarily. All 10 could be in the 400mg arm if placebo and 300mg, and 400mg met the 162 (total) and 27 subjects, respectively. The 3:3:1 trial design may have had the possibility of adding patients in mind if the 400mg arm appeared to have stronger numbers based on raw blinded 27 patient results.
Why would they recruit 10 addtl patients?
Anybody?
Actually, 12 cohorts and no dose limiting toxicity (DLT), which made the maximum administrated dose (MAD) the maximum tolerated dose (MTD). That was the absolutely best outcome for the trial since the MAD was 200% above the highest anticipated effective dose allowing lots of room for adjustments in this first round of dose optimization, Phase 2a for OC and Kevetrin characterization.
Bullshit. Each successive milestone has been reached at minimal dilution. Aspire has been a very low dilutive financing source. One cannot find another biotech with 5 drugs in Phase 2 and only 40 million shares diluted after 7 years.
Bullshit. Each progressive step has been successfully completed. Most important, there have been no trial failures. 6 for 6, 100% success rate. Every month Leo and IPIX complete a new milestone.
Typical end of August hand-wringing and price activity. Things and sentiment will change with September. Count on it.
Yes, we do. There were complaints about slow progress from all interested parties. There were especially pointed complaints about the long delay in assays, which took almost 2 years between the first and next.