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I've posted it many times. It applies to IPIX as it applies to all other companies. If I have time in the next day or two I can pull it.
Yep demand is low, but the pps is set by the Market Makers. Of course they are sensitives to reality, but they are most sympathetic to their own desires to make money.
I agree, demand would help. But the MMs have raised pps in the face of low volume/no demand situations, too. Presumably to try and stimulate a little interest. They can't make any money with no turnover.
The pps can also rise because the Market Makers see something to convince them to do so. They set the price. So far, at least, they remain unconvinced.
"But FDA clearance for use of this laser in patients with epilepsy is at least three years away"
The two docs that run BeaMed seem legitimate and sharp. I am wondering why IPIX did not just make an arrangement to fund one of their approved uses, though epilepsy surgery seems too new and unique a 510 use to slip by as substantially similar to an existing product and use. If even a small group of patients is successfully treated in an FDA 1 regarding laser treatment of epilepsy, it may draw the interest of BP. In fact, perhaps that is the whole point of this new process -- get recognized by a BP and sell/license quickly. I never worked a 510 when insurance was a significant factor, your mention of it here is relevant.
Yes, typing too fast. Lotrimin. Worked like a charm. Scary exercise, though.
Just anecdotal. Went to a hospital for one-day surgery and came back ok, except for fungus on my inner legs. Took trips to two docs to get Losartan prescribed. Worked. Same time a friend, on vacation a couple of hundred miles away, got it on tip of his tool. Need to call and see how it worked out, and if he has any idea where he got it. Could mean nothing. On the other hand I never heard of such a thing, ever...... It would be good if Brilacidin got some recognition if warranted, or at least some support for a full FDA test run if it look like there is a chance it can be effective.
"And of course, BP can certainly move in an buy a smaller company if it really sees that its drug/pipeline has the potential to be lucrative...which has not happened here"
Maybe most of our products just aren't worth much?
"FDA ain’t corrupt. Not perfect, but not corrupt."
Correct, but it is too often bought and sold by BP on its study panels, regulatory reviews, etc. Corrupt no, but too often heavily influenced by BP at the expense of the consumer, of course. On the other hand so is most of government. Sorry for butting in, but I've seen it too often real time not to comment. Until elections are publicly supported, not privately, and lobbying strictly controlled the merry-go-round will continue.
As noted, I stopped trying as Leo never returned my calls, emails, etc. Must have been something I said.
He has been selective regarding those he has responded to, starting more than a few years ago.
"Some of the Prominent Therapies in the Oral Mucositis Market Include:
Avasopasem manganese (GC4419): Galera Therapeutics
Brilacidin: Innovation Pharmaceuticals
CareMin650: NeoMedLight"
I loved reading that, but is it really accurate? IPIX never finished an FDA 3 and the data in the FDA 2 was not stellar, as I recall. Indicative yes, but not "blow away". Really needs an FDA 3 success to be worth anything. And as time passes it has less and less value.
Sounds kind of familiar. GLTY
"Leo is feeding us crumbs. We need the entire Meal. I'm really hoping for the BeaMed boys to take over the helm!!!!!!"
I wouldn't mind that at all, but if I had a choice I'd rather see Alfa Sigma buy our IBD uses, or even the whole shebang, with whatever value there is. It is almost BP size, and that presents opportunities that we can't even imagine with Leo's small salary machine.
"I am flabbergasted at the number of people who still believe in IPIX."
Not sure lots believe in IPIX deeply, just that lots have never sold, kind of been rat fked.
'"Pending" and "discontinued" are very different'
Ha, not with IPIX.
I agree the post was not news. But it is a legitimate piece of information by a company providing paid analysis under the Springer banner. Springer is a legitimate organization that publishes a wide variety of books and other materials, as your are probably aware. I bought a Springer published book a few years ago when I was helping a little company do 510s. However, what interests me most about the post is this: "Discontinued: Intestinal infections; Ophthalmic infections; Ulcerative colitis." It does not seem to be worth $50 for a subscription if all one is researching is IPIX, but as a general tool, it could seem to be a real time saver.
You're right on the money on this. Also, same thing with mold, mildew and bacteria, in different forms. I am always amazed that ......F'it, said it too often.
"One would think that if the drug had the extraordinary potential proclaimed by some, Alfasigma would have been more active in getting those trials started."
Are you also figuring n the effects of covid in N. Italy, which were particularly harsh?
Gawd, LR, Phenomenal research. In truth I had just started looking for the oral treatment of ABSSSI and don't think I would have had as comprehensive a go at it as you just did. Many thanks.
"I would be happy to learn more about your pill."
Interesting, guess I got you riled up a bit, sorry for that. I meant no offense to your positions as stated here often enough. I do feel that if there were a pill, that stocking an iv treatment from IPIX would not be something that would be likely. My opinion of course. Now I need to find where I thought the reference to a pill for ABSSSI were to be found. I'll look bright and early tomorrow. The real problem is that if the treatment were so effective, even given some side effects, why hasn't it been bought up by BP. It has been endlessly discussed here, all sides of the argument, but none of course can be proved. Only Leo knows, and that is tantamount to bag holders never knowing what he knows. .
The 7 day versus one day is a great point, though I thought I'd read of a pill for ABSSSI which would blow any comparative arguments, unless dealing with already hospitalized patients. I don't think hospital formularies would ever approve and stock an iv drug used that rarely, maybe if IPIX were a BP.
"I'm in for BeaMed and the anti-fungal so hope springs eternal"
I'd add the N. Italian IBD study, that could range between a game changer and nothing at all.
The only other glimmer of hope is that B for ABSSSI may have some relevance as the need for alternative bacterial treatments intensifies. But I, for one, reluctantly support your general conclusions. Hard not to.
As I recall the billions for Moderna and Pfizer were given out as part of the Warp Speed initiative, They got money develop the Covid vaccines, which had mostly already happened, but to guarantee the market for them. I was surprised to see the media trumpet Warp Speed like it caused the vaccines to be developed when that was clearly not the case. Yes BP and Trump, Biden or whoever is President are partners it seems. Little guys, not so much.
I haven't done this for a long while, but I went on Google Scholar and entered Kevetrin and was surprised to see at flock of scholarly articles re Kevetrin, seemingly a dead issue, at least for IPIX. Why didn't Leo just sell it, or maybe he tried and there were no buyers, as I've said too many times before!. Be nice if the bag holders knew. Frustrating, at best.
"I decided to type in Kevetrin and seen that Gilead sciences applied March 3 2023 as the applicant for a patent for K. Just saying…" If IPIX owned Kevetrin but has never attempted to fully develop it, is the implication that Gilead bought it from IPIX? What is your take?
Of course the PR today was good news. But one thing still bothers me. If some of our other potential products are as good as we might hope, why hasn't NIH offered to fund them? For NIH they are all mostly small change. Is Leo that much of a dork to deal with, or are some of the potential products just not that hot? WTFKs
You know, Shazam, after 7 years I really don't have a firm idea of whether the pps action is based mostly on what real buyers respond to, or just Market Maker estimates, along with some self serving plays. It is, after all, the MMs that really set the price. If they are too off the mark, the stock will stagnate with few or no buyers and sellers, I would guess. Maybe that is what has happened here. Whether you're high on the stock or not, the last couple of PRs, sketchy as they were, were good news, accompanied by pps stagnation or drops. For this reason I see the effects of MM paly here more than on other penny stocks, but I have no valid way to compare.
"If I used the term "investors" I regret it....."shareholders" is the appropriate term."
Uhh, I think "bag holders" may be the more appropriate term.
I agree it is a good (and hopeful) article.
But if it is real why have no BPs stepped
up to buy this Brilacidin use? Leo does
not appear to be an effective CEO, but he
doesn't appear to be a complete idiot either.
In fact he takes care of himself and his friend
pretty well as he dilutes common shareholders.
You raise an interesting point. If the laser is SE (Substantially Equivalent) to existing devices then the pathway to approval could cost less time and money . But if the system is a novel system, really unlike any other, then the more costly PMA (Pre-Market Approval) would likely be required. Really can something be first in class and yet SE to an existing device or devices? Let's hope it can.
Below is a cut from the FDA PE rules and below, the PMA rules.
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and does not raise different questions of safety and effectiveness; and
the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices needs to be identical. FDA first establishes that the new and predicate devices have the same intended use and any differences in technological characteristics do not raise different questions of safety and effectiveness. FDA then determines whether the device is as safe and effective as the predicate device by reviewing the scientific methods used to evaluate differences in technological characteristics and performance data. This performance data can include clinical data and non-clinical bench performance data, including engineering performance testing, sterility, electromagnetic compatibility, software validation, biocompatibility evaluation, among other data.
A device may not be marketed in the U.S. until the submitter receives a letter finding the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:
resubmit another 510(k) with new data,
request a Class I or II designation through the De Novo Classification process
file a reclassification petition, or
submit a premarket approval application (PMA).
Who is Required to Submit a 510(k)
Overview
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval. Please note that some Class III pre-amendment devices may require a Class III 510(k). See the PMA Historical Background webpage for additional information.
PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.
The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval of Medical Devices. A Class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act and may not be marketed.
When a PMA is Required
PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices. Device product classifications can be found by searching the Product Classification Database. The database search provides the name of the device, classification, and a link to the Code of Federal Regulations (CFR), if any. The CFR provides the device type name, identification of the device, and classification information.
A regulation number for Class III devices marketed prior to the 1976 Medical Device Amendments is provided in the CFR. The CFR for these Class III devices that require a PMA states that the device is Class III and will provide an effective date of the requirement for PMA. If the regulation in the CFR states that “No effective date has been established of the requirement for premarket approval,” a Class III 510(k) should be submitted.
Please note that PMA devices often involve new concepts and many are not of a type marketed prior to the Medical Device Amendments. Therefore, they do not have a classification regulation in the CFR. In this case, the product classification database will only cite the device type name and product code.
If it is unclear whether the unclassified device requires a PMA, use the three letter product code to search the Premarket Approval (PMA) database and the 510(k) Premarket Notification database. These databases can also be found by clicking on the hypertext links at the top of the product classification database web page. Enter only the three letter product code in the product code box. If there are 510(k)’s cleared by FDA and the new device is substantially equivalent to any of these cleared devices, then the applicant should submit a 510(k).
Furthermore, a new type of device may not be found in the product classification database. If the device is a high risk device (supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury) and has been found to be not substantially equivalent (NSE) to a Class I, II, or III [Class III requiring 510(k)] device, then the device must have an approved PMA before marketing in the U.S. Some devices that are found to be not substantially equivalent to a cleared Class I, II, or III (not requiring PMA) device, may be eligible for the De Novo process as a Class I or Class II device. For additional information on the De Novo process, see the De Novo section of Device Advice.
Always good to see you here, Farrell. I share the belief that Alfa Sigma will continue its FDA cycle with Brilacidin for UP/UPS. Why not, they have the money? I also believe a successful trial could mean a move by them to purchase some or all of IPIX. I know some still have hopes of an OM or even an ABSSSI use of Brilacidin, but Alfa Sigma seems our only practical/real hope at this time. I don't know enough about the laser therapy option to comment one way or another, but this could reflect a good purchase, we can hope. Again, always good to see you post here.
Not much, If it really worked, there would have been better options.
Same old, same old.
"The Company wrote off the patent costs relating to Kevetrin of approximately $141,000 during the fourth quarter of 2022 due to discontinuation of its Kevetrin program."
We're all aware of the cancellation of Kevetrin. Wouldn't it have been helpful to give the stockholders an idea why, like maybe Kevetrin does not really work, or it may kill the cancer but it also kills the patients, who knows? Or we don't have the money to do an FDA 2 and 3 and no one else wants to buy all or part of the rights. It reminds me of Prurisol, which failed an FDA2b as I recall, but the complete data set was never shown to anyone outside of the company. That was inexcusable. By that time lots of us were in too deep to bail, though, in retrospect that might have been a wise idea.
Hard to say. Betting none at AS
Thanks for spending some time on this LR. I'm still of a mind that the covid issue may have slowed down or otherwise complicated the IBD related AF test. We'll see.
"And Alfasigma has been sitting on B for years."
Takes time to do a study right. Nothing shocking here, especially with the problems caused by covid making any study start more difficult. By the end of the year we'll likely know something imo.
Frenchbroad, did you read any of these? Did you use JSTOR, or pay, or use another way to get access? If you read either or both, what was the essence? I am guessing any IPIX role is based on B for ABSSSI in the FDA 2(b) or something I am not aware of? I can't see Leo borrowing over 34 million to do the FDA 3, or even selling the franchise to a BP who might. But that would be good. Something, anything is better than nothing.
Appreciate the dd, where did the quote come from?
Why wouldn't IPIX do a pr based on this PubMed article? We see potential uses of IPIX products every few months, but nothing ever seems to come of it. Regardless, nice catch.