On the other side of the world.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
It’s news to anyone who does not know it. I think there is a just a little bit of snark.
I prefer to just call it Wednesday, the weakest day of the week.
Ghost town?
“Followers: 759 - Board type: Free - Posts Today: 120”
It was just over 600 followers a year ago. Daily posts have ranged from a dozen to over 400. Seems quite average as we are in a 3 month anticipation period.
Don’t forget about the CDAs. I’m sure there is something in the boilerplate parts that have something to say about insider buying, explicit or implicit.
Now your argument is pure stupidity. No, Leo will not take just any offer.
I’m not the one who said a BP could buy IPIX with petty cash. No they can’t. Or, do you disagree?
likewise Leo isn’t going to sell IPIX at pennies on the dollar for 7 Phase 2 drugs. So, your statement that a BP can buy the company with its spare change is silly, as I originally said.
This OTC where scam stocks have astronomical values while companies with real drugs in real trials and no failures often get hammered down. Up is down, left is right and real is imaginary. There is very often a massive disconnect between share price and intrinsic value of products in progress. That disconnect remains until value becomes irrefutable.
$5 billion is petty cash to a BP? That’s the minimum value at this point. There is nothing for OM and UP so they are each blue sky drugs. Thinking IPIX will go for pocket change is silly.
Follow up on Ziagen vs Prurisol doses: Ziagen is 300 to 600 mg PO qDay, or 1200 to 2400 mg total every 24 hours. P doses were 300 and 400 in 24 hours.
The bridge study was designed to show similar safety to Ziagen. The FDA accepted that. The mouse studies showed dose dependent efficacy. It’s not unusual for humans to require greater quantities of drug (gms/kg) to show the same therapeutic benefit. Again, we will know soon enough, but so far all evidence points to the same dose dependence with safety expected to exceed 600 mg. The current trial didn’t exceed 400 mg. Ziagen administration is 1100 mg, if I remember correctly. Correct me if I’m wrong.
No, the 505b2 pathway only applies to safety, as far as I know. Someone else may know better than I. The advantage comes from mouse studies in parallel with human performance, so far. That is, efficacy in mice was dose dependent. We will know soon enough if that increased efficacy continues beyond 200 mg. All evidence points in that direction and that safety should extend beyond 600 mg.
As explained in the bridge study, which was accepted by the FDA in the application for a 505b2 pathway, both breakdown to abacavir in therapeutic use. Yes, abacavir is not the active moiety, but that has nothing to do with proving safety.
OK, first, IPIX share value is in the process of realization as the next milestones will prove out. Second, one cannot first claim to trade precisely pennies buying bottoms and selling tops and then expect a “where is mine” result. Third, one must first purchase shares on a real exchange and not the FNTC exchange to expect some return. If after all these years of trading those precise tops and bottoms, one then claims not to have gotten his/hers, then one must be a (fill in the blank).
All nonsense and false blame. Leo and Sullivan eliminated the threat of unresolved legal actions that must be included in quarterly and annual filings. Without that elimination the forces of evil would point to that again and again as proof of malfeasance. Already, Leo is blamed for share price collapse instead of those who rail against the company ad nauseum. It’s a sad era when corporate trolls making stuff up have more impact than actual progression of science.
Dosing level is based on abacavir because that is the basis for the 505b2 pathway. It is not because Abacavir is the active moiety. Please note the difference between abacavir (the generic) and Abacavir (the specific salt of abacavir.
Leo successfully defended IPIX against spurious lawsuits. That is the return to shareholders: not having to include pending legal actions in Qs and Ks.
Those conversions are only used for determining a safe starting dose in any escalating safety trial. Phase 2 includes safety at escalating dosages to determine optimal dosing range. Published studies on mouse to human conversions recommend not using it without human data and to never use it to determine expected efficacy ranges. In the case of P, there already exists 20 years of human use for drugs that are salts of Abacavir and reduce to abacavir.
And, yes, we know the doses administered to mice. They were published long ago.
What utter nonsense. I have never seen a deal without an upfront payment and the licenses picks up the remaining costs to approval and market. Even a partnership includes a large upfront with the partner picking up at least half the cost.
As OM is a blue skies drug with well over a billion potential market, I would expect a multiple of $10 million, all future costs covered and a double-digit royalty. That’s just how it’s done.
The milestones have to be met by Sept 30, not by Sept which would be Sept 1.
I’m not predicting anything. I’m stating valuations based on specific events, outcomes and drug performances. There is a big difference between the two.
Please read this and see what you think:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=141976339
This is a phase 2/3 biopharma with late stage trial(s) pending. It’s unrealistic to think Leo can more than $20 billion pre-revenue and $10 billion post-Phase 2 even with 7 drugs across 3 platforms. There is still a lot of work left (reformulations for 3 drugs) and a lot of time and investment left for a partner or buyer. There is also the issue of legacy royalties for B and K which reduce valuation on a tax. Also, I can find no precedent for 10s of billions even adding the values of similar deals for 7+ drugs across 3 platforms.
First, an outright buyout should fetch $5 to $10 billion. Depending on a lot of factors, B platform is currently between 3 and 5 billion based on current proof of safety and efficacy, market size and blue skies OM and UP. Prurisol would fetch 1 to 3 billion and K 1 to 2 billion as a safe and proven p53 modulator. There are plenty of examples for those valuations for phase 2-3 drugs and includes BTD and 505b2 pathways. It also includes greater than 30 PASI75, but also its value as an anti-puritus should it be less than 30 PASI75.
Second, it’s unclear what deals Leo is pursuing. We can only guess. If it is a license/partner then precedent shifts downward. If Prurisol is successful in phase 2b, then I’m pretty sure that will be the first agreement. A 505b2 pathway drug would get $30 million to $75 million upfront with a few $100 million in milestone payments how many millions depending on the backend royalty structure. The money would then be used for further development of B and K. OM would be the minimal go to if P shows a low PASI score. That should get $45 million to over $100 million upfront, again depending on the backend terms.
Third, the previous paragraph takes the IPIX cap to $1 to $2 billion, $4 to $8, on a spike and then pullback to roughly half that. As trials ramp back up, and key milestones are hit (including first market approval), the SP over time might approach $40 to $50 a share and even later after continued success, new partners and approvals finally reach multiple 10s of billions. But, that’s far in the future.
Bottom line, $15 to $40 a share for the whole kit and kaboodle will change the finances and retirement for a lot of people, as would even $5.
Well, 2 months with good behavior.
Even if IPIX gets 10 mil —which would be for only 1 indication—to move one other drug through the next level phase 3 it will take $15 million more. So $10 million plus another $5 to $7 million that Aspire is on the hook for, covers a second drug through another trial, such as UP. Then a second more lucrative license or partner for an advanced stage drug.
No one is saying that at all. No one is claiming there should be no human trials. That is your red herring argument. What we are saying is mouse models are a great indicator for what to expect in human trials.
What the mouse models tell us:
* Prurisol is safe up to at least 600 mg a day.
* Prurisol efficacy is highly dose dependent.
* It is an immune regulator/modulator.
* It not only reduces, but seems effectively to cure psoriasis in human tissue.
All of the above showed strong signals in the underpowered Phase 2a study and is further reflected in the design of the phase 2b. There is a metric tonne of evidence that phase 2b could further reflect high efficacy equal to that of the competition, and absolutely none that it could fail. Yes, we should be aware that there is a chance of failure; no there is no evidence that it has. None.
It is not treating or curing psoriasis in mice. It is treating or curing human tissue in “humanized” mice. Dr. Menon’s adapted HUM/SCID mice have proven to be highly reliable over the past 25 years.
Yes, Leo has some idea based on raw data. Please reference anything Leo has said or released that indicates any results.
What part of blinded until locked do you find confusing? Maybe I can help sort through it all.
But the placebo showed no changes in the assays while those for the treatment groups showed increasing responses to increases in dose. One must not ignore that part.
Anytime from next week until Sept 30 top line results can appear. But, wait a minute, an agreement with double-digit upfront payment is also baked into the Aspire deal, and there has to be time between top line and finalizing a deal. So, top line in a few weeks.
Few weeks = weasel time line
Indulge me, what does it mean to meet the primary endpoint for the Prurisol trial?
Data base lock means that all data from the trial, including follow up and questionnaires, have been collected and nothing more can be added for analysis and submission to the FDA. It means top line results of the trial is only a few weeks away.
And a contingent guarantee to buy 5 million more for another $1.9 million, which is $6 to $9 million. Also, check the math on the % fully diluted. I’m no mathematician, but I think the 12-15% is inflated.
Please note the guidelines say (if you are copying and pasting)
“Timelines for FDA response:
Within 60 calendar
days of receipt of the
request ”
It’s a response and not approval or disapproval. A response can range requests for more data and answer questions, to suggestions for what the FDA’s BTD might entail, to approval or disapproval. So, a BTD approval can take far longer than 60 days including any back and forth, request and response.
Menon is a scientist. Chief regulation is science; it’s not financials and corporate governance. Any advisors rated pro knows the difference.
Menon is a scientist, not a CPA with an MBA like the CEOs. Another reason that the first CEO was let go.
That’s correct except that the drugs he worked on went into clinical studies and needed to be reworked after several issues came up. His team did much of the reformulation and Menon was one of the certified toxicologists and pharmacologists. This was in addition to mouse wrangling for those studies.
Me on didn’t fabricate anything. He earned his PhD from Kerala University while working as a lab technician and mouse wrangler at Harvard’s Beth Isreal. Dr. Emil Frei was his mentor for the doctorate in Pharmacology. Some promoters inflated his credentials including the original CEO of CTIX.