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What happened to the FDA needing to see the interim? Now, no AA? There’s been nothing to suggest AA is off the table. We always knew CMC was a major hurdle. You’ve gone too far with this post.
I think you are spot on!
I’ll stay quite for a time and see if Leo can pull something out of the rubble for the sake those who are still in.
No, I just finished selling my shares and the shares of my kids, extended family and friends. But I’m not gone. I will stick around as long as the carnival barker draws a paycheck from shareholders. I’ve been here a long time and I’ve paid very close attention. I’ve met Leo personally, and I should have sold at his limp hand shake.
How about a 30 patient open label trial? We are going to give you the SOC plus this treatment. It would sure tell you if it didn’t work and be informative on all secondary outcome measures.
Simultaneously, run a second open label on patients immediately upon testing positive. We’ll start your IV right now, and pay you $xxx.xx to come back each of the next two days and then a phone follow up. I’d do this now vs the Merk drug.
Interesting that UC is listed as discontinued?
Is “Everything advancing per industry norms and standards”?
Concluded
Enrollment Results Days Enrolled Sites
CYDY 12/15/2020 3/5/2021 80 P3 394 18 USA
HGEN 1/29/2021 3/29/2021 59 P3 520 29 Int
RLFTF 12/30/2020 2/10/2021 42 2b/3 196 10 USA
IPIX 6/3/2021 11/8/2021 158 P2 120 12 Int
CYDY reported on a trial more than 3x the size in half the time.
HGEN report on an internation trial, more than 4x the size in a little over 1/3 the time.
RLFTF reported on trial 50% larger in 1/4 the quarter the time.
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No. I’m skating to where the puck is going to be...Replacing Humira. I’m not excited about about UP, but I’d like to see the entire digestive track available for sale.
You have ignored the claw back provision. The can’t just sit back wait for IP to progress the IBD. I would expect they would forfeit their right of first refusal if they fail to perform. That’s why I would be busting my ass right now to fulfill the the terms of the agreement, just to keep UP. They won’t be able to match the offers that are coming for IBD.
Leo stated at the sh meeting that there were claw back provisions if AS did not perform. That is my hope. If I were an AS exec right now, I’d be busting my ass to get a trial going, given the last few PR’s. I hope we claw it back. A deal made in desperation. Then we would have the entire digestive track to sell.
Mic drop
I give TIAB credit for calls he’s made in the face of the ridicule he has received from this board. With all the IMHO on this board, it’s a FACT that TIAB has been right. He said the Prurisol P1 results were too weak to warrant a P2. Correct. He said the delay in P P2 results foreboded bad news. Correct. He said the B OM data was too weak to partner. Over 3 years now…not wrong.
Now let’s go to present day…WTH is taking so long?! I agree with TIAB…what happened to April? That line that “we had to wait until the BP drugs got the first look” is BS! There are many microcap stocks that are far ahead us (CYDY, MESO, CAPR). Even my dog’s heart worm med is being studied. The delay is baffling. Is it a conspiracy? Or is it Leo or his reputation?
Let’s take MESO’s April for one example:
3/10: The Company is in “active discussions” (sound familiar?) with various government and regulatory authorities, medical institutions and pharmacological companies to evaluate” is product candidate in patients w/ARDS caused by Covid-19.
4/6: FDA approves IND for Compassionate Use and P2/3 trial
4/8: P2 trial announced
4/24: Report out on Compassionate Use
4/30: Begin P2/3 enrollment in 20 site, USA trial enrolling 300 patients
5/6: 1st patient dosed
5/13: Raised $90 mil to ramp up manufacturing
However, I do disagree with TIAB on B for CV. I think he’s putting too much emphasis on Leo’s track record and not focusing on the scientific strengths of B. I think we are beyond the point of Leo’s carnival barking or incompetence. B beat the best antibiotic on the market, with a one-and-done (this is now of value). This confirmed its cell wall piercing MOA. RBL 1 shows a 60% knock down of the virus. It has pieced bacteria walls in human, the CV wall in monkeys…piercing the CV wall in humans is not a stretch.
The before and after pictures of the UP trial show B’s anti-inflammatory capability. Though not “proven”, genuine potential of this MOA is confirmed by AS. It’s the cytokine storm that is killing people. If B does to epithelial lung tissue, what it did to epithelial colon tissue…???
Finally, in the 1918 pandemic, most people died from the secondary complication of pneumonia. If B was safe and hugely successful in ABSSSI, is pneumonia a stretch? It’s as if B was meant for this crisis.
If and when B does succeed, I will let my family and friends think I was a genius, and you can think that of Leo, but I will consider myself lucky, and thankful that I was part of helping humanity through it’s most trying time in modern history. And wise for doubling my position during the Covid crisis.
I’m a long-term long and I’ve never bashed management, but I can’t let this praise of Leo go without responding. IMHO, this is the worst managed company I’ve seen in my almost 40 years in business.
I have lost a lot of money here, because, in the void of information, I made the mistake of attributing to management the common business sense I would use myself, and expect of any competent business person.
I won’t Monday morning quarterback their decision to pursue P, but their management of the P2 warrants criticism. I asked Leo at the shareholder meeting, why they didn’t take the “planned” interim look at P. He said, “The results came in too slowly, so they just had to plow forward to get the results.” There so much wrong with that statement.
First, you negotiate into your agreement with the CRO, timelines, deliverables, communication expectations and accountabilities.
Second, you stay on top of the project. Why was the enrollment slow? Why select testing sites that don’t give your trial the agreed upon priority of patients? WTH was Jane Harnes doing?! And why is she still here?! Why were there significant cost over runs, and why weren’t they contractually limited? And most unbelievable of all…how could a CPA not have properly planned for the trial expenses? They just surprise you with a $2M cost overrun? Come on!
Thirdly, after foregoing the interim look, they plowed through for 7 more months and millions of dollars. Find a way to look at some data or Case Report Forms.
Leo is praised for being frugal. Going into the Prurisol P2, the sp was $1.50+. Why didn’t he raise cash then, GOING INTO A P2?! Frugal? or just stupid. I don’t know if the failure to up list was truly due to not meeting the requirements or he decided not to do it.
Then there is the office lease. He entered a 5 year, $20k a month lease without a confirmed need. At the sh meeting, he said, doing trial tasks themselves saved money, and “we also needed a place to store our records.” Huh? What trial? And move your records to a storage locker!
The Aruda patent infringement. Oh, Menon paid for that mistake. But wouldn’t you think you would have your legal IP t’s crossed on your company’s core asset?
Then there’s the Carnival Barker Leo. It cannot be denied! Just look at the summer of 2018. How do you set 3 milestones, have your financier make a public statement of them being likely achievable, and then not achieve a single one of them?! This is just the cap stone. How many times over the years did the words, “in the coming weeks” appear in PR’s? Eight months ago, he told me he would soon reveal his plans to “grow the company”. Did I miss something, or was that the “planned” UC P2 trial with no announced funding?
At the sh meeting, I asked what happened to all the high hopes for B Absssi? He said, it didn’t make economic sense. Huh? I invested because I bought into the looming global antibiotic resistance crisis. Then there was the Merck acquisition of Cubist for $9.5B. Only to be told now, that the economics weren’t there. Why did they do the P2? Did they not understand the economics? The crisis has only gotten worse. Leo and Menon have long said the anti-inflammatory properties of B were of more valuable than the antibiotic properties. Then why did they focus on an economically unviable indication?
Sorrento’s existing state-of-the-art cGMP antibody manufacturing facility in San Diego is expected to be able to produce 200,000 doses per month and the Company intends to produce a million doses at risk while seeking FDA approval.
Anyone wondering why Leo doesn’t purchase shares on the market? Why, when you can just issue yourself options for a half mil at $.10. And that half mil each of those 2 board members got was well earned.
Nicely done. Thank you. I never understood how B could be used as a vaccine adjunct.
Capricor (CAPR) has a drug, CAP-1002, that was first tested in 6 ARDS patients on vents via the compassionate use. All 6 came off the vents. They are expanding it by 20, and planning a placebo controlled trial on moderate and severe patients.
I would expect that’s how B will progress.
By the way, this drug reduces the cytokine storm.
It all hinges on B for CV testing. AS is required to advance the drug in an agreed upon timeframe, or rights can be clawed back. I doubt the exception of a “pandemic” was a provision in the agreement. If B proves out vs. CV, IPIX is catapulted into a whole new valuation. If AS is not able to perform, due to the devastation Italy and the world has suffered, we claw the rights back. We then own the rights to the entire digestive track, are renowned and well capitalized for saving the world from CV, and may even have an aerosol delivery developed at no cost, opening up many new big $ indications for treatment. It’s mind boggling to think that this is very possible for a $.15 stock.
Why does it list B as “antibody” and not antiviral or immunomoduator?
Gov. Cuomo said today that “No American is going to say accelerate the economy at the cost of human life.”
He hasn’t read this board.
I’m intrigued by that last sentence. I thought the company returned all the other UPenn IP due to financial constraints.
I asked about the timeline at the shareholders meeting. Leo said that maybe in another month they’d be able to update shareholders on that. I was expecting more than...we met.
Yes. That is almost exactly what they said.
I attended the meeting. They took questions for about an hour.
Question was asked why there is even a need for a B-OM P3?
The FDA needs to verify safety. Mgt said that B was embraced by the FDA. The fact the FDA has approved moving forward with P3, with such a modest sample size is impressive. The FDA is fine with the primary endpoint being high dose every 3 weeks. The trial size requested is 300 active drug recipients. They would go 2:1 drug:placebo, so 450 trial size. They said that the FDA even offered suggestions for improved labeling. However, the Break Through Status fell through due the results of the weekly cisplatin. The EMA wants the whole population. They said they will look at both groups and are “harmonizing” the requests.
They said BP is not interested in cancer support, so it is mid to small companies that are in the data room now, and that they are in talks with them about licensing deals. The AS upfront will be disclosed in the Q. It has not been yet, so as to not show all your cards the B-OM negotiation. So…I believe it will be very small. The main purpose of that deal was validation and the data that they will receive to support B’s effectiveness in the larger indication of IBD.
I asked what was AS’s expected development timeline? They said summer is a down time in Europe, and that Joint Development Committee will be meeting and they should know more in about a month. They noted that in the B-UP trial, they dosed via a crude enema, and that AS would be developing a commercial drug, testing safety and then a controlled trial. AS has to develop in earnest or they can claw back the asset.
The B-IBD pill trial will start in December (wiggle room) and go quickly. I asked if the next step would be another proof of concept trial like B-UP? My thinking was that we licensed B-UP from an 18 patient, open label trial, so repeat that with B-IBD. They said, that BP wants to see a 2a. BP told them that if they can show them a successful 2a, they will be “knocking their door down.“
The first term sheet fell through due to a change in management. The new mgt wanted to focus on their existing business and did not want to go off in any new directions.
I asked why they renewed the lease and what are their plans for it? They said they intended to use it for a P3. They saved millions in the P 2a doing work in-house vs. paying a CRO. They have engaged a realtor to sublet all or part of it.
I asked why the Ireland office? They said they need it for future dealing with the EU for approval of drugs. If they are going do trials in Europe, they need an EU office. Also, having an EU office saved them a significant amount of money (90%) in scientific consulting. I didn’t understand this, but I didn’t get the opportunity to ask clarifying questions.
Why was the SH meeting in GR? Dr. B lives in Ann Arbor, and that they are using ex Pfizer exec’s that he has worked with in the past, as Tox consultants. Didn’t say which drug(s) they were consulting on. They did say they were half way through with the toxicology work on Kevitrin, but I think they said that a year ago too.
Leo said he doesn’t read the message boards. The FUDsters are still active on a 13 cent stock so they will never have to cover and pay taxes.
At the end, Leo said that he will provide more clarity in the coming weeks. “A new direction, a new understanding of what’s going on, actually growing the company, not shrinking it.” They may engage a P/R firm…long overdue!
Asked, what are the prospects for a B-OM deal? Leo said he couldn’t say, then Dr. B spoke up and said, “I’m still here after 3 years, and if I didn’t believe, I wouldn’t be here anymore.”
I didn’t hear anything, but I thought the MFO might be RDV Corporation. That would explain why the meeting is in GR and the Devos family has in interest in health sciences.
See you there
No B-OM deal coming. In Dr. B’s quote, “we are committed to advancing B across multiple IBD indications...like our P3 ready oral rinse Brilacidin program in Oral Mucositis.” B-OM in the same sentence as IBD following, “At the same time, we are excited to be underway with our own B oral formulation efforts.”
Your argument supports the justification of their $450k compensation (which I’ll address in another post), not whether it should be in cash or stock. As a long time shareholder, who has gotten in too early trusting in Leo’s PR’s, I would feel better knowing that they were being paid in stock. If I were in their shoes, knowing the potential of “nearly 20 CDA’s” and two non-binding term sheets, taking stock in stead of cash (at least in part) would benefit them and the shareholders.
By the way, if improving the mfg process of B is an accomplishment, what do you call spending $1M on bulk mfg of B over a year ago?
Then be compensated in stock instead of cash.
Oh, I thought you were going to say 2 months since the non-binding term sheet PR, or half way through summer, or 1.5 months until we get another PR stating... “Now that the holidays are over...”
So if they face another law suit, their defense will be poor judgement and incompetence. Pretty sad for a Michigan grad.
Excellent post.
I agree with you, Leo will be going it alone for IBD p2. Why else would we be developing the tablet? And I would agree with the decision, if we got the funds needed from a UP deal. A deal from a successful p2 dwarfs what we would get now.
Aren’t the trials referred to as starting late 2019/early 2020 testing the delivery/safety of the tablet? A p2 would then follow some time later?
How would we tap Aspire again, when we were over $.25 a year ago and they had to cut another more expensive agreement with Aspire to get funds?
What would be the purpose of publicizing a non-binding Term sheet? I can’t see how that could enhance your negotiating position.
This technology is readily available today. The probiotic I take has dual encapsulation. I don’t understand this gastric fluid testing and even why testing a non encapsulated formulation in a human trial?
How do you know that the meeting minutes will be made public? If a BP was in attendance, the company is not saying. Why does receiving written minutes change that?
If they have BTD, what's your scenario for no announcement yet?
The current financing terms limits the MFO to 10% of the outstanding shares.