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""Ask Alfasigma. Two word reply!"
What are you referring to? As I understand we may get no info re Alfa Sigma till late 2022 or 2023.
"I think a lot of lessons learned from this study."
That's a nice. positive spin. I think some longs on this board could have designed the study differently, and probably moved away from the facility-based IV given past peak viral loading.. By the time patients were on IVs the damage that you described was mostly known. Leo took a dumb shot with our money, and lost. Big time.
"That's exactly correct - it's called an analog."
I found that the second and third, etc. finishers often appeared in the larger markets, where even a few percentage point coverage would spell financial success for a small company. I would really love to see more about the market in general, to make some guesstimates about what the longer term benefits of spending this 4 million will or could bring. I was always surprised that no one got sued for just plain ripping off another's designs, but never saw that happen. But, as I said, I was far from an expert, just another guy who did analog product research.
I worked on a few 510(k)s a few years ago (did product research). If you can prove, with working models, advertisements, pictures, etc., that your device is very similar to an existing approved one, as I recall, the process can be shortened a bit.
"Time to make a few bucks on this dog and pony show.."
How do you propose on doing that?
So, would a wise investor have sold at .035, planning to re-enter in the low 2s? I didn't, but then I'm not really a wise investor from the looks of my shrunken cache.
"I believe next week news might be from Alfasigma. Viva Italia!!!
Based on? I've been trying to get info on this for months, but like others have failed.
"True, but speculative run to .20-.30 not crazy either."
Would be nice.
We've all (Well lots at least) seen this before; modest, really modest news, up a good percentage, and then a slower drift back. For one thing, it just gets me more let down with Leo. He was too cheap or hesitant to invest in a treatment method that could be given when patients are just infected. Maybe he tried a couple and they were ineffective. If Leo learned this, his burying the information would not be illegal, and quite in line with the toxic secrecy we have seen here. Who knows? No matter how you cut it, professional investors will not be sending this to .50 or 1.00 on strength of slide or test tube successes with Brilacidin for covid, or anything else. Although the findings provide some hope. Wise investors will determine a bail out point and will recoup some, but there are few wise investors left on this board. Sorry for the repetition, but we've been here before. Good luck to all longs, we still need it.
I agree Mack, what a DFT to say, cut your losses and sell at a bit over 2 cents.
Great find, I blew by that observation. Guess they felt the cost was only justified if there were only good information presented. I stopped buying these types of analyses a few years ago. Mainly useless, imo.
Minnesinger you make valuable points. Let me also add that going with the present products costs way more money than IPIX has, recall that a few years back finishing the ABSSSI testing would have cost 34 million. I always felt that the money should have been borrowed, as anyone could see the future was raising the needs for new antibiotics, especially ones that can deal with MRSA type organisms. There was already a market with more to come. But Leo was very cautions and chose not to put himself in any risk. Of course there were some side effects, but effective medicines usually have them. So here we are. As noted, we need an annual meeting (even an informal one held by longs if IPIX does not have one) to try to relieve him of his "command" so to speak. I know, very unrealistic, but would be nice to try anyway. What have we as longs got to lose, that we haven't already lost. Leo's salary never bothered me until he chose to play small ball with a Covid treatment and kind of sunk our boat. But he or his buds didn't lose a nickel in salary. That's the rub, for me at least.
In yesterday's NYT Lora Kelley did a story on how much founders of companies should carve out to pay themselves. She says on average $100,000 or between 80 and 180,000 annually . I have called IPIX a shell company, and to some extent that is not fair because it has done the failed Prurisol (Really, a pretty well done shot imo) and an ill-conceived Covid test (The compassionate use off-shoot was worth about nothing for IPIX), some incomplete FDA tests and one legitimate license in well over a decade (Alfasigma). How does he and staff/officers stack up (pretty poorly, imo) .
We need an annual meeting, somewhere in the central USA so we can try and challenge this CEO. I have no ideal if the longs could pull it off, probably not, but I'd sure travel a bit to give it a try. My 60-70K is now less than $7,500 if I sold this morning. For me, that is reason enough to invest in a day or two of travel. WTF.
https://www.nytimes.com/2022/06/17/business/startups-founders-pay.html
"And the anti-virus possibilities of Brilacidin are not finished with just one trial."
I tend to agree, but would say it has never really been tested adequately in vivo. The covid test was on patients for whom the virus had already done levels of moderate to serious damage. It never addressed the pre or non-admission patients in whom the virus was still very active. Of course Leo would have had to invest in a test for a treatment that was not IV administered. He took a longer shot than necessary, many of us here said F it and went along for the high leveraged potential. Better luck next time .I don't consider it negative to say investors here rarely if ever get a full picture of what has happened or is happening.
Nice to see you post grumpini, is this a good or a bad sign?
Of course, but why ask such an obvious question?
'Every person in the government (including the FDA, NIH, etc) is for sale at the right price'
If you really believe that, you are way off base. Guess I should have held out for some illegal payback. When I was with FEMA ( a few years) I never heard anyone say, "You FEMA guys go home with your medical teams, rescue and clean up teams, water, help with insurance forms, low interest SBA loans, food, places to stay. You are all dishonest and for sale to the highest bidder, and I want nothing to do with the lot of you." Nope, never heard that.
"I'm not saying the FDA is corrupt through and through but apparently there are opportunities for pharmas with deep pockets to get their way."
In my view, nicely stated. And I worked with those guys for decades in emergency management. The problems are systemic. As long as elections are paid for by big buck contributors (what you are saying, right?), they will have their way in writing regulations that favor big pharma, just how it is. What lets me down are the GS 13-15s who really run the agency, review the studies, set the meeting schedules. They often seem blind to reality. For example, during covid instead of working with CDC to develop great and cheap test kits very quickly, they put up procedural road blocks requiring incessant reviews, testing until the time had passed and, after a year or more, there really were no test kits out there that were inexpensive and widely available. But their meeting schedules were met and all the procedural niceties that led nowhere. I was degusted, because these are smart guys who could have done way better. I expect political appointees to be overly sensitive to big donors, but the professionals dropped the ball too.
Unfortunately, what you write is true, and there is no apparent reason that we will ever know anything more about Kevetrin. No BP stepped up and Leo never allocated the money (borrowed it). Really sad, as Kevetrin might have been a contender. It is Leo's constant secrecy that bothers me most. Unfortunately, I and other longs are just along for the ride. Why sell, at less than 3 cents?
Last time I looked, months ago, before the covid fall, almost a thousand. Of course, less now. Ok, you're looking at aliases. Can't argue that that is not a real, but surely indeterminate group. Point is that it is not a large group. Hundreds, less? You're making my point that there is not a lot or even growing interest in following or buying IPIX right now. Wish there were.
I am saying that IPIX is thinly traded, and that doesn't seem to indicate strong or growing interest. If you are referring to heightened scientific interest, that would be great, but I don' see that either.
PJ, I value your insights but I guess we see this differently. There have only been 307,000 shares traded as of a few minutes ago. With maybe 1,000 board members (though most have gone inactive) and well over 400 million shares out, 307,000 doesn't show much interest. Many longs posting here have that many shares, though I am speculating about that.
Ok, maybe I was too quick to criticize another payroller. Maybe we can get rid of the first two, and just keep this guy. Can we get a shareholder vote on that?
"Got to hand it to you. You are amazingly consistent in your content and approach to the postings here. Good job."
Cannolliman, I wish I were consistent at something around here. Leo has some potentially good products, but here we are getting pulled along on his S....ride to somewhere, I'm not sure I want to go. Oh, and he keeps the salaries coming, and even brings on another, to do what? besides getting paid. It's very disillusioning.
"And people, thankfully, stopped getting infected."
As noted, it did not happen by accident. The US CDC led the World Health Organization in the successful efforts to immunize the remaining pockets, until there were none. Brave CDC folks as well as others, tramped all around Africa and Asia to get the job done. Not private business, or bogus contractors, but government in one of its finest hours. There is a sample of the virus in a bio level 4, as I recall. There have been arguments about destroying them, for safety, but as I also recall, wiser heads prevailed and government still has a sample locked away. Or did last time I heard of the issue, maybe a decade and one half or so ago. A really good book was written about it 10 or 12 years ago, but I never read it.
Your point is well taken, but in my view it is more than just "a pinch" it is 42% or so succeeding through the FDA Ph3 , though you used the covid example, and I am using data based on all FDA testing through a few years ago.
From PubMed Central
2019 Jun; 4(3): 428–437.
Published online 2019 Jun 24. doi: 10.1016/j.jacbts.2019.02.005
PMCID: PMC6609997
PMID: 31312766
Phase II Trials in Drug Development and Adaptive Trial Design
Gail A. Van Norman, MD*
Author information Article notes Copyright and License information Disclaimer
This article has been cited by other articles in PMC.
Go to:
Summary
Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success:[ >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design.
"he's telling you everything he wants you to know"
Which is close to nothing.
There is an Alfasigma group of about 66,000 or so on LinkedIn as I've mentioned. I cruised around a few times and found very little but nice company good feeling type PR stuff. I had a few colleagues from HHS/ASPR/BARDA also on the website, but can't find them. Soooo, who knows, maybe not even The Shadow. I've sent emails to the company and have received no response. But as it is private, as I've been told, and we are not and can not be stockholders spending time with us probably won't happen..
I was referring to Spot's response, not to you Frenchie.
"clinicaltrials.gov is of course an NIH site, not an FDA site"
I think you may have been a bit flippant about clinicaltrials.gov being an NIH site and not an FDA site. It is an NIH cite but it is entirely devoted to FDA test issues. You'd be hard pressed to even find the term "NIH" in this federal description of the site (though it does appear in a few places). Below is a bit of a long piece, but it makes the point. Ok, this is not the biggest issue we have to dealt with, just sayin'. IPIX has a relationship to FDA, not so much with NIH, only indirectly, as I see it.
FDA's Role: ClinicalTrials.gov Information
What is FDA’s Role Related to ClinicalTrials.gov?
The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the “Responsible Party” for certain clinical trials register with, and submit the results information of some trials to, the ClinicalTrials.gov databank (www.ClinicalTrials.gov).
FDA has been given the following implementation and compliance/enforcement responsibilities related to Title VIII of FDAAA:
Requiring a certification regarding compliance with ClinicalTrials.gov requirements to accompany certain human drug, biological product, and device applications and submissions to FDA.
Requiring the inclusion of a particular statement in the informed consent documents for “applicable clinical trials” (trials that will be entered into the ClinicalTrials.gov databank as required by FDAAA).
Compliance and enforcement activities related to the failure to submit required clinical trial information to ClinicalTrials.gov under HHS regulations at 42 CFR Part 11.
The operation and development of the ClinicalTrials.gov databank and the drafting of regulations related to the databank are the responsibility of the National Institutes of Health (NIH)/National Library of Medicine (NLM).
What Does FDA Require Regarding Certification?
To certify compliance with ClinicalTrials.gov requirements, FDA requires that applicants complete and submit Form FDA 3674 with certain human drug, biological product, and device applications and submissions. In general, FDA recommends that a Form FDA 3674 accompany the following applications and submissions to FDA:
Investigational New Drug Application (IND)
New Clinical Protocol Submitted to an IND
New Drug Application (NDA)
Efficacy Supplement to an Approved NDA
Biologics License Application (BLA)
Efficacy Supplement to an Approved BLA
Abbreviated New Drug Application (ANDA)
Premarket Approval Application (PMA)
PMA Panel Track Supplement
Humanitarian Device Exemption (HDE)
510(k) submissions that refer to, relate to, or include information on a clinical trial
Note – FDA does not require the submission of a Form FDA 3674 with an Investigational Device Exemption (IDE) application, as this was not required by FDAAA.
What Are the Informed Consent Requirements Related to ClinicalTrials.gov?
The following exact statement must be included in the informed consent documents of “applicable clinical trials”:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
FDA has issued guidance related to this new informed consent element.
Historical Background Information
The Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law 110-85 (September 27, 2007), amended the Public Health Service (PHS) Act and is designed, in part, to promote transparency of clinical research to trial participants and the public.
Title VIII of FDAAA amended the PHS Act by adding new section 402(j), 42 U.S.C. § 282(j). The new provisions require that additional information be submitted to the clinical trials data bank (www.ClinicalTrials.gov) previously established by the NIH/ NLM, including expanded information on clinical trials and information regarding the results of clinical trials.
HHS issued a final rule, which is codified at 42 CFR Part 11, as required by Title VIII of FDAAA, to clarify and expand the requirements for registering clinical trials and submitting results information. [September 21, 2016, 81 FR 64981]
A certification of compliance with ClinicalTrials.gov requirements is required by 42 U.S.C. § 282(j)(5)(B), section 402(j)(5)(B) of the PHS Act. The certification requirement went into effect on December 26, 2007. To assist sponsors, industry, researchers, and investigators in complying with the requirement, FDA created a certification form to be used to satisfy the certification requirement. This form is Form FDA 3674, OMB Control No. 0910-0616.
As required by FDAAA, FDA published a final regulation (21 CFR § 50.25(c)) [January 4, 2011, 76 FR 256] amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information may be entered into the ClinicalTrials.gov databank. Compliance with this new requirement was effective on March 7, 2012.
Related Information
ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions
ClinicalTrials.gov regulations (42 CFR Part 11)
Details of the statutory language of Title VIII of FDAAA
NIH Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial. (NIH site)
Form FDA 3674 (including instructions)
FDA Guidance on Form FDA 3674
FDA Guidance on Informed Consent Elements at 21 CFR 50.25(c)
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
Questions Related to ClinicalTrials.gov
Any questions related to the following should be addressed to the ClincialTrials.gov staff at the NIH at register@clinicaltrials.gov:
Regulations at 42 CFR Part 11
How to register studies and enter clinical trial results information
Technical issues related to submission of information to the ClinicalTrials.gov databank
Questions and information (other than technical issues or complaints) related to compliance and enforcement of NIH ClinicalTrials.gov databank requirements can be addressed to FDA at gcp.questions@fda.hhs.gov.
Complaints should be reported to the office handling the type of study involved. FDA contact information for complaints.
Office of Good Clinical Practice
Office of Clinical Policy and Programs
Food and Drug Administration
10903 New Hampshire Ave., WO32-5103
Silver Spring, MD 20993
301-796-8340
"1980 — the result of an unprecedented global immunization campaign.""
Actually, a huge and successful effort led by the US, CDC in particular and by DA Henderson in particular. Back when the US led the world in public health spending and effectiveness. Long before antigovernmental ideologues damaged the US public health capacity and assets at local, state and federal levels. And yes, I met him, but did not really know him.
You know, I think I actually recall that post. I bought more. This time I took a pass.
And an earlier one.
https://cheng.matse.illinois.edu/files/2021/02/2021-Jiang-Yunjiang-Advanced-Drug-Delivery-Reviews.pdf
Would have been nice to pony up the 34 million to try what looked like a high probability chance on the Ph3 trial for ABSSSI. If successful would have had legs to apply in other, related applications.
Here's something that seems to say it all. From Stocktwits:
"$IPIX
Can someone who understands accounting explain this to me? How does IPIX w/ 4 employees have $1,480,000 in Accrued salaries - related parties.
When I google Accrued salaries, I get Accrued salaries refers to the amount of liability remaining at the end of a reporting period for salaries that have been earned by employees but not yet paid to them. This information is used to determine the residual compensation liability of a business as of a specific point in time.
I wouldn't expect 4 people in a not profitable company to make that much all year.
If you are going to reply with nonsense, please stop and let someone who knows what they are talking about speak"
I haven't verified anything, but it does seem to be accurate.
https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html
Not sure if this (from 2019 originally) has been posted. Is this what it would take to get Kevetrin approved? I just can't go with that though, in honesty I am not sure what a realist cost estimate would be. Of course Brilacidin for OM, ABSSSI and IBD will have to meet much lower cost thresholds, but still, maybe $100-150,000,000 or so to finish all three, of course hoping for a final, positive Ph3 for each. Valuing IPIX for any potential future sales will have to deal with thorny issues like this. Of course Leo is up to it, right? And recall, with the massive dilution so far, even a net purchase price of $100,000,000, which is lots of money, would net shareholders maybe a quarter to 20 cents a share. I know BPs have paid more, but lots have also paid less for little bios with a few products. Alfasigma, a "mid size" pharma apparently has the economic heft to do it, but would it want to (of course assuming an eventual positive on the Ph2 of Brilacidin that we can hope is just starting).
Thanks, hope it's for more a few pennies. I bounced around on the extensive Alfasigma site and just was not able to find anything. Though the company is making a big display of its IBD prowess and the many millions across the world affected by variations on this painful theme.
So, what's your take, Pheonix300?
"Tricky to give an IV drug for five or three days to an ambulant population"
I'm aware of the IV
I can see that, though experimenting with an injection or even an inhalant might have been just the ticket to address the early, mild to moderate patients. A cynic might believe Leo figured nothing would come of it but a good, but a temporary pps boost.
I don't have much faith but am not really briefed well on the recent push to develop IV infusion center businesses. See https://stepbystepbusiness.com/business-ideas/start-an-iv-hydration-business/
Spots, you have made your point well about Brilacidin's side effects, even circling the fact that there is much less of a BP issue than with daptomycin. We've all seen these before, and before, but your perspective is a healthy one, and tends to keep longs grounded in a semblance of reality. TIAB used to do that, now he's gone. Of course I like Frenchie's points about FDA and the tests, too. Still relevant. So there we are, awaiting a more definitive read from a Ph3 for ABSSSI, which may never happen.
And less BP issues
Last three times or so we got "big" bumps, as I recall, it was merely shake and bakes. But maybe... if it were a fact based bump, what is the fact set?