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And it was pretty funny. But your analogy of riding in a car with chattering, sniping, witless, inexhaustible kids in the back seat "before computers" was a gem.
Glad to see you're hanging on and hanging in. Let's get this show on the road.
Thankful indeed, although "I don't know who pulled this particular string" dribbles a little piss in the welcome punch bowl.
Decades to death.
oh good grief.
"'Worthiness' is a criteria now? I didn't see that in any of the FDA Guidance material."
If a claim is made about a drug's efficacy to do a certain thing, and if that claim is deemed unworthy or undeserved or not sufficiently demonstrated by the FDA, even if the drug is otherwise quite safe, you'll be bound to label graphics that state: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, cure, or prevent any disease." You might have a couple things in your home right now with this statement of undetermined worthiness.
What is your opinion then as to the current status of things between IPIX and the NLM on B-OM's 3rd Submission Cycle? According to the listed definitions, it is waiting for NLM Quality Control review.
And what would be your opinion if next week there is a 12/18/18 date listed in the adjoining Results Returned column? The submission is pending changes by the the sponsor, from what I read.
No, of course not. But that's quite different from the quoted questions. If no agreement is reached with the FDA on whether B-OM deserves to advance its candidacy, at the meeting, on that very day, then it's time for IPIX to throw the shovel in the wagon and call it a day.
I believe, at their meeting, IPIX and the FDA will reach broad agreement on the worthiness and safety of B-OM to be given to more human beans that could benefit from it, and that that will have significant impact on IPIX's future. And of course, there will be details to be monitored and issues to resolve in the planning and execution of B-OM's Phase 3, and some of those may not be resolved, or even anticipated, on the day of the meeting.
If you click on the glossary term in the column just to the right, the Results Returned after Quality Control Review, it reads:
"The date on which the National Library of Medicine provided quality control (QC) review comments to the study sponsor or investigator. The sponsor or investigator must address major issues identified in the review comments. If there is a date listed for results returned after quality control review, but there is not a subsequent date listed for results submitted to ClinicalTrials.gov, this means that the submission is pending changes by the sponsor or investigator."
I've studied on this for a while as I've wondered some about IPIX's apparent decision to run B-OM's P3 trial with self-dosed and -administered sachets, and if the FDA was going to be cool with that, and if some back-and-forth with the NLM was any indication of un-coolness.
But the two columns on the clinicaltrials.gov results page and their glossary terms are contradictory. If there is a date listed in Column A but not one in Column B, it means things are under review by the NLM. If there is a date in Column B but Column A is empty, it means the sponsor needs to change something. And then we go back to Column A.
It's an illogical perpetual motion machine. I've decided it's not very important.
"The only aspect of the issue we're raising that that statement doesn't address is 'What happens if there aren't "Any agreements reached during the meeting"?' or if there are issues upon which the parties don't agree."
Simple. IPIX will never see a share price in the teens again.
B-OM trial record updated again today, er, yesterday.
https://clinicaltrials.gov/ct2/show/results/NCT02324335
Where's the rumored Merck? And JNJ may be laying low in the acquisition market and conserving cash for a while given the news on them today.
"What next? A P3 trial - unless there is partner available IPIX cannot start P3 trial due to lack of fund. "
Doesn't get much more binary than that, non?
Agree with you. But the results of the EOP2 meeting, I believe, will either float or founder the SS IPIX. My money of course is on the former. Whatever the result of the meeting with the FDA, the cascade of follow-on events and decisions will occur in fairly short order. Within 5 weeks, an IPIX share price in the teens will never be seen again.
You don't need a million dollars to know the answer to that question, though there are millions to be made (or lost) once the question is answered. IPIX gave you the answer 3 weeks ago, on Thanksgiving.
"In just a few short weeks, we will be convening our Brilacidin-Oral Mucositis End-of-Phase 2 regulatory meeting. Success here not only would help us to complete development of the drug, but also to advance other aspects of our clinical pipeline."
Hard to be more clear than that. It's a binary event coming up. The victory - or the defeat - precedes the battle.
Maybe the reason that things aren't working out as you'd hoped is due at least in part to the odd investing strategy of buying high and selling low.
"just filled a buy at .131 - this pig is going much lower"
IPIX is a decades to death investment.
I long for Prurisol's P2 results to be released so I can tell you everything you want to know about that.
I don't mean to demean or malign your report. The answer to your question though just seems like a really easy get. Even if I only had $100K invested in IPIX, and a doctor with a lot of knowledge about antibiotics told me that he knew about significant safety issues with Brilacidin in its clinical trials, well criminy, he couldn't kick me out of the clinic until he'd shown and told me everything he knows about the subject.
If your doc has his drug candidates confused, you can double your share count tomorrow morning and get your basis to less than $1.00 for, probably, less than $8K.
I'm sure you asked your urgent care physician his source for this unpublished information, yes? If not, given your distress, I'm sure you'll phone him up tomorrow with the question, yes?
"But if the EOP meeting is successful, IPIX should see a partnership in the near future - whatever that means."
There are lots of caveats before that and a few after, but for me it means: "Success here not only would help us to complete development of the drug, but also to advance other aspects of our clinical pipeline."
For me it means a new investor buying 100,000 shares of IPIX tomorrow morning for most likely less than $15K is making a cheap, wise wager.
Two minutes of a given day can stretch right out into hours when you're looking for something you want to see, waiting, and looking again.
https://bleacherreport.com/articles/2809529-alex-smith-reportedly-battling-infection-after-surgery-on-broken-leg?utm_source=cnn.com&utm_medium=referral&utm_campaign=editorial
"...removing tissue to clear the infection..." and "...may need partial reconstruction surgery [due to tissue loss]..."
Been there, done that.
I assume Mr. Smith was receiving quality, high-dollar care at a quality, high-dollar facility.
MRSA is an unrelenting bitch. Let's get Brilacidin to market IPIX.
What attention to detail, for a company already deemed to have failed, so badly, for so long.
"This has been a good stock to watch. The end game should be just as interesting as the run down to 14 cents." OK.
Just me, but time is short, and frittering hours tuned in to a "chart (that) remains one of the most broken I have ever seen" seems a waste of anyone's talent and opportunity, regardless of mileage. Rubberneckers get good mileage, creeping along the highway hoping for a glimpse of gore in the wreck beside the road, but they don't cover much ground, and they just slow everyone else down.
I don't have enough time to figure out what to get everyone for Christmas.
I don't know. Should IPIX have had the foresight to base their original NDA application on the use of sachets? Maybe, but at-home use may have been dictated after 6/28 by their BP fiance'. Did they need to start a new NDA for B-OM once the sachet road was obvious? I don't think so, but it added time, complication and certainly some cost.
A non-disclosure agreement might keep IPIX quiet about the status of their BTD application, so might an understandable reluctance on IPIX's part to fess up that their BTD was rejected when their share price already can't break a wind. My swag is it's something different, and my swag is it might have something to do with this, from the 7/17 PR announcing IPIX's collaboration with CoreRx: "Sachets are planned to be used in the continuing clinical evaluation of Brilacidin for the indication to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy."
Are sachets exactly the right way to market Brilacidin for an OM indication, so potential OM patients can mix them and use them at home? Yup. Does CoreRx have lots of experience putting dry powdered drugs into sachets? Yup. Is this the way the drug was packaged, mixed, and administered in the pertinent trial? Nope. I don't know the primary packaging used to ship Brilacidin to the clinical sites, but I'm guessing it wasn't a sachet substrate. I do know the drug was mixed with USP water (aka "water for injection") at the trial sites, and likely measured and mixed by a pharmacist or a caregiver.
If I'm the FDA, given the 7/17 news, here's what I'd want to know:
- results of accelerated and long-term stability testing of B granules packaged in the selected sachet substrate, meaning what do the sachet substrate and its contents do to each other if they're sitting on a FedEx trailer in Arizona for 36 hours at 150 degree ambient, or a Seattle warehouse in high humidity for 26 weeks
- what is the air permeability rating of the substrate, and does B efficacy degrade in extended air exposure
- does the selected substrate have any history of delamination, discoloration, or other adverse reactions
- what happens if Brilacidin is mixed into particularly hard or soft chlorinated tap water, instead of USP water
- what happens if some idiot drunk and blind with pain mixes up 9mg/ml instead of 3, and swishes and swallows it
The milestone agreement that included BTD for B-OM as a source of funding was announced on 6/28, three weeks before the CoreRx PR, but the landscape apparently and obviously changed soon after. I think sachets is and will be the right, most lucrative way to go for B-OM. And like more than once in IPIX's record - P3 ABSSSI or bust! - not taking the most direct route to commercialization has proven a test of shareholder patience.
But lordy at the shares I bought today.
Not really. Same thing happened yesterday.
No, I have found no examples of the FDA not meeting the 60 day response time.
Understood on the 60-day clock, although already in 2016 there's hints that the FDA is having trouble keeping up: "So why does the FDA want to bring some changes to the BTD process/program? It is because the increasing BTDRs are putting a burden on the FDA and its ability to handle these requests. Thus, enters FDA’s ‘preliminary BTDR Advice’ system."
From: http://www.ask-cato.com/looking-for-a-fda-breakthrough-therapy-designation-btd-utilizing-the-preliminary-btd-advice-system-might-be-useful-or-not/
Slide 34 of http://www.brookings.edu/~/media/events/2015/04/24-fda-breakthrough-therapy-designation/breakthrough-therapy-slide-deck.pdf shows resubmitted BTDR's for the period Q3 2012 through Q4 2014. A total of 203 BTDR's received during this period; 7 resubmitted after denial, 3 resubmitted after a withdrawal. Of the 10 resubmissions, 4 BTD grants.
If IPIX's BTDR was denied, but the reason for the denial is easily corrected and the BTDR is resubmitted, should they inform the shareholding public? Probably. Do they have an obligation to do so?
I'm curious if the involvement of the NLM could've had any effect on timing and result of a BTD decision. I don't have a clue.
At least it appears that whatever communications or queries were involved, they were readily responded to by IPIX.
Thanks for the info.
"Few", not "several".
And "short" ones at that.
Maybe you missed the memo. Brilacidin has already been tested in humans for treatment of distal IBD, and in a small sample size it appeared to work like a champ.
FDA input on B-OM's trial results to date and guidance on a Phase 3 plan will go a long way to inform IPIX's (and possibly a partner's) thinking about B-IBD advancement given the similarities in drug administration and indication being addressed.
Here were my thoughts after reading IPIX's Thanksgiving message:
- there is nothing here that can be construed as insider information, but
- if you know anything at all about IPIX's current state of clinical and financial affairs, this is about as close to insider information as it gets
- because
- it emits a signal that an imminent, meaningful financial gain will result from a "successful" meeting with the FDA, and
- failure in that meeting may not be an option
"Are you saying that the "lives to fight another day, or they don't" outcome rides on the FDA's approval or disapproval of the Company's B-OM P3 plan?"
Yes. I believe that approval is the trigger for a Brilacidin deal to be consummated. I also believe Brilacidin for an IBD indication will be in play at the upcoming meeting, not the oral, mid-gut version, but the topical treatment of inflamed, compromised mucosa at each end of the gut.
IPIX lives to fight another day, or they don't. One, or zero. At 12 cents per share, the binary-ness of things gets right down alongside the bone.
"I'm inferring.....that any approval or disapproval on the part of the FDA regarding a trial entering a new Phase would be based on safety and not a decision based on the review team's perception of a given candidate's efficacy or even the true value of the trial itself in that regard. Would you agree with that?"
Yes, mostly.
I would not agree with this: ".....it is the Company that will have to decide whether to go forward, assuming that the protocol and package don't reflect any safety issues in the FDA's view." I disagree because it implies that the FDA is just some casual, almost disinterested observer checking off a few safety boxes, and as long as those boxes are checked the Company has carte blanche to move forward with whatever next-phase human trial they want to design, administer as much of their drug candidate to as many people as they want, or not.
"Really? What do you mean by 'approved the advancement'?" I'm not sure why that's such a riddle. Whether you're a $120B pharma, or an IPIX, if you want to advance your US-market drug candidate into the next phase of its clinical trials, the US FDA must approve that advancement. Would you agree with that?
"IPIX is a decades-to-death investment."
Makes sense to me.
It's extraordinary to me how much power FDA regulators hold in evaluating data from a clinical trial and then preparing for and conducting an end-of-phase meeting and delivering their decisions on a drug candidate. Both lives and fortunes can be gained or lost in the process if they do poor work or don't make a good decision. And generally, almost always, the FDA makes good decisions.
Even more extraordinary to me, given the amounts of money usually involved, is that the process is so rarely corrupted. Government gets a lot of bad knocks, but good government works wonders, and is irreplaceable. When government agencies work the way they should, their efforts toward bettering the common good are almost invisible to the broad public.
Imagine trying to get a useful (and demonstrably safe) drug approved in *let's say* Venezuela if you don't have much time or money, versus trying to get a competing useful (and demonstrably deadly) drug approved if you have a suitcase full of Swiss francs and a brother-in-law on the approval board.
The United States FDA has so far met with IPIX a few times and on each occasion has approved the advancement of its three (did I say three?) drug candidates for their next human trial, across multiple indications. I'll look forward to their next decision "in just a few short weeks".
Short, my ass.
I've been out of touch for a while and just read this for the first time. I see that, since this email was sent to those on IPIX's mailing list, about a quarter of a thousand posts were made here, and I'll guess quite a few of them pertain to this brief missive. My immediate take is:
- there is nothing here that can be construed as insider information, but
- if you know anything at all about IPIX's current state of clinical and financial affairs, this is about as close to insider information as it gets
- because
- it emits a signal that an imminent, meaningful financial gain will result from a "successful" meeting with the FDA, and
- failure in that meeting may not be an option
My 2 cents. I'll look for IPIX to keep me apprised of Company developments, as promised. Let's get some Prurisol data. It's gonna be good.
“Let people start using them at their own risk,” O’Neill has argued.
I wonder how that's going to work out. But I don't have to wonder very far.
They do indeed. Leo owns quite a few of them. The popular notion that Leo is living large off his salary and doesn't give a crap about the price of his shares is a ship for fools.
It's a good read, certainly topical. Only thing I found curiously lacking in the decision tree about The Asset is the point where you should ask yourself, "Is my Asset worth a shit?"
And then IPIX flounces in the door with three Assets, and things get exponentially more complicated.
It sure takes some saltpeter to be long IPIX these days. On paper, my investment is red as a beet. Emotions and fight-or-flight adrenaline bust in the door on logic, flip their middle fingers. Logic jumps off the sofa and runs out the back door.
And then I just have to stop and do the math. It goes like this: my estimation of IPIX's current value of its science and drug candidates, divided by the number of IPIX shares, times my number of shares. And then I'm good.
When it comes to the estimation of future value of IPIX's science and candidates the edges of my math get wide and volatile. I could get far, far beyond good, or not. IPIX could be worth nothing more than it is today. But that's the future. Worst case, I'm still good. I'm relishing and learning from the ride.
The people buying and selling IPIX shares every day, the "market", believe I'm an idiot, that a share of the company is worth a fraction of my current value estimate. Who are these people trading less than 1% of IPIX shares each day and determining corporate value and therefore the cost of raising the capital that IPIX needs desperately? It's not me, I only buy. It's not the majority shareholders. It's just small-potato folks who are betting IPIX will run out of money before they can bring a product to market, or that IPIX's management has somehow so far successfully hoodwinked both the FDA and the SEC.
I like my bet better.