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What you discount is abundant evidence that Prurisol efficacy is dose dependent and safe up to 4 times the highest for 2a. I’m not talking about the graph for 2a; I’m talking about the preclinical data. Yes, it has to be proven in 2b; no we don’t know anything yet. Pretending to somehow know otherwise is a fool’s game, as in a king’s fool.
What makes you think he’s not in talks for both? There are 3 platforms so he could easily be in talks for each one, any 2 of the 3, or all 3 as a single deal. He would not be able to talk about anything more than what was approved by CDA holders (assignees), depending on each holder’s interest.
Sachets are nothing more than another way to package a drug. The only real questions are 1) is the packaging and drug as stable as it would be if premixed and bottled (I’m assuming it’s premixed by a pharmacist) and 2) can patients be expected to follow procedures as outlined in the directions for use? Question 1 falls under CMC, which must be completed before the next phase whether 2/3, 3 or 4. IMO it’s highly unlikely a trial will be required for a generally well established method of delivery for an oral rinse. Instead, the use of sachets would be integrated into whatever protocol for the next phase.
No. He resigned from NNVC in 2007.
I could not agree more with all of this:
“Toughest part of investing is right here and right now for most. There is nothing negative - just delays and uncertainties and a very unusual string of occurrences.
Three options
-buy more
-hold
-sell
It’s not tough. Everyone has the power to decide.
Quiet periods can make one a lot of money. Do your own DD”
No, I think he meant fleckless:
“Definition of fleckless. : free from flecks; especially : flawless. —Merriam Webster
Fixed it, thanks.
A clinical trial result becomes a reportable material event if those results become known publicly or to non insiders such that the information would impact share price or other valuations. That is, it becomes tradable information.
“...the link does not support the idea that the receipt by management of a clinical trial result is always a material event that requires reporting.”
A clinical trial result only becomes a reportable material event if those results become known publicly or to non insiders such that the information would impact share price or other other valuations. That is, it become tradable information.
I believe the above to be a correct interpretation. Please correct or feel free to add.
This may help you sort the differences between a 505b2 pathway and the yellow brick road that Dorothy followed. Hint: the 505b2 pathway is real.
“About the 505(b)(2) Regulatory Pathway”
https://www.herontx.com/about-the-505b2-regulatory-pathway
More like common nonsense.
Re: ...ipix has no competitors because they have no products for sale,
You are saying “the competition” only includes approved drugs? What about the competition toward drug approval, say oral mucositis? Are there not at least 4 drugs in Phase 2 in competition with B-OM in the race for approval?
Re: ...no fda approved drugs, no drugs in a phase 3,
See above as well as note there are no Phase 3 drugs for OM.
Re: ...no way to fund a phase 3, no concrete plans to start a phase 3...
There are many ways to fund a Phase 3 trial. There are many strategies left untapped by Leo that can easily be deployed. However, most involve paid promotion to front run funding, something Leo has not yet done. Also false about concrete plans; all plans are on hold until Prurisol results are in. How Phase 3 is funded is highly dependent on Prurisol outcomes and that 505b2. You should read up on the 505b2 pathway; it’s very enlightening.
You get the picture?
It is nonsense. It’s false equivalence. You accused me of using the absence of data to support an argument, much like someone else did. Example of absence or data as evidence: there was no Prurisol PR and its den a long time between the last patient and unblinding; therefore, Prurisol failed. Absence of data as evidence is atypeof non sequitur.
Also, doing it again, you are pointing out a conditional projection, then arguing it must be wrong even though those conditions for IPIX have only just come to pass.
Yes, 505 needs are speculation regarding IPIX, but those needs are real and factual. The 505b2 pathway requires greater care in collecting, compiling and confirming data, that is a fact. Whether or not it is one of the reasons for the long period between last patient final visit (LPLV) and unblinding is speculation.
Nonsense. Those were estimated valuations based on evidence from similar drug deals and based on specific outcomes. I did not use the absence of data as proof of thesis. I was also upfront about future possible conditional values and that it was speculative.
I still stand by those values since historical evidence has not changed, other than drug license valuations have increased.
Averages are exactly and only that, averages. As was pointed out sometime ago, sometimes those averages include up to a year between trial completion and unblinding.
It’s not an extraordinary delay. Such time frames are not common, but when dealing with 505b2, it’s often enough the case.
Actual facts:
*Unblinding and data release can take more than 6 months.
*Data collection when accompanied by a survey adds time and must be compiled and analyzed before data lock.
*Data lock means nothing more can be added or changed including questionnaire results.
*The time before unblinding and data accuracy becomes especially critical when a 505b2 is involved since the object is to jump to a small Phase 3 trial or even market approval under a Phase 4.
*CROs tasked with data collection and compilation across more than 30 clinical sites makes unblinding even more time consuming.
The above are facts. Claims that 190 days indicate failure is as far away from being factual as any conjecture can possibly get. One might even call it fiction.
This is the original post:
“Using patient questionnaires/feedback or anecdotal stories (like poster nerby) in lieu of credible scientific data from a randomized, placebo controlled study is how patients can be harmed and medical research corrupted.”
No one has a problem with “anecdotal stories”, But many of us have a serious problem with this “Using patient questionnaires/feedback...” when it’s followed by this “...is how patients can be harmed and medical research corrupted”
The post I’m responding to walks back the original.
FYI: “As of 2018, the Saturn V remains the tallest, heaviest, and most powerful (highest total impulse) rocket ever brought to operational status, and holds records for the heaviest payload launched and largest payload capacity to low Earth orbit (LEO) of 140,000 kg (310,000 lb)...” wiki
I guess “most powerful” includes the SpaceX heavy-lift that sent a Tesla Roadster into space.
Yeah, I’d say IPIX is a Saturn V on the launch pad.
A deal should not be struck until they know if B-OM will be awarded BTD. That takes several months for the filing and review. The BTD is worth hundreds of millions more than without.
You do understand that a deal 1) usually takes a year or more; 2) can’t strike a deal until the Prurisol value is affirmed; 3) negotiations are from license of a single indication, to an entire platform, to the entire company; 4) all takes more than 6 measly months.
It’s likely that there are several deals in place waiting for final data and analysis. That’s what those last bottom line OM subgroups were in part all about that some keep ridiculing.
“As a holder of more than 600k shares for myself and clients,...”
I don’t believe this for even one moment.
10 million upfront is ridiculous for an urgent need treatment with a blue skies market upon approval, and IPIX has 2 of them B-OM and B-UP. There are plenty of examples of just plain old market licenses and partnering exceeding $50 million upfront up to over $200 million.
Check these eye popping numbers as a few examples:
“In an attempt to boost its earnings in the near term, AstraZeneca also furthered its externalisation strategy in 2015, receiving US$200 M upfront from Daiichi Sankyo in return for US co-commercialisation rights to its opioid-induced constipation therapy MovantikTM (naloxegol) (Deal no. 63995). It later out-licensed its immune checkpoint inhibitor MEDI4736 (durvalumab) to Celgene for development in haematological malignancies in return for US$450 M upfront (Deal no. 64454), licensed brodalumab to Valeant Pharmaceuticals International for US$100 M upfront (Deal no. 66380), divested Caprelsa® (vandetanib) to Sanofi’s Genzyme unit for up to US$300 M (Deal no. 65743) and sold US rights to Entocort® (budesonide) to Perrigo for US$380 M (Deal no. 68043) and ex-US rights to the same drug to Tillotts Pharma for U$250 M (Deal no. 65472).
Intent on reclaiming market share lost to Gilead Sciences’ Harvoni® (ledipasvir + sofosbuvir), in
May J&J’s Janssen Pharmaceuticals licensed worldwide development and commercialisation rights
to Achillion Pharmaceuticals’ lead hepatitis C virus (HCV) assets, including its Phase II second- generation NS5A inhibitor ACH-3102, with the aim of developing an oral treatment regimen that could work in as little as 6 weeks (Deal no. 64761). The deal, the company’s largest of the year in terms of headline value, is notable for the absence of an upfront payment, with J&J’s venture capital arm instead making a US$225 M equity investment in the HCV drug developer. Otherwise, J&J’s deals were very much biased towards the early stages of development. In November, for example, and in exchange for US$105 M upfront the company’s Janssen division licensed worldwide rights, excluding China and Korea, to Hanmi Pharmaceuticals’ oxyntomodulin-based therapies including HM12525A, a biologic that is completing Phase I and which is expected to enter Phase II studies in 2016
(Deal no. 67761).
Source: https://www.pharmadeals.net/journal/pharmadealsreview/fulltext/pdf/2148
OK, so you know a conversation that has never taken place based on questions never asked and follow up questions only anticipated and not those that might occur in the actual moment. You are right, such incuriosity would waste your time.
I made the trip and learned a great deal. They answered all my concerns except those few that involved inside info. With your ( verifiable) md background they would happily make room in their busy schedule to meet with you, maybe even do lunch.
One has to wonder if a tonne of excuses for not going reveals a fear of actually learning something, and the dismantling of a carefully constructed belief system.
I thought you had it right the first time: “The bug SQUEEZE is on!”
Price and trial success for a drug still blinded is a false correlation. One might even call it the worst of false flag indicators. In fact, if anything, it’s actually an inverted correlation. There are myriad examples of price collapses ahead of successful results. There are even more examples of high speculative buying ahead of failed results. Based on my vast experience in this sector, this fear selling should be followed by very positive Prurisol results, possibly even spectacular given the steep decline.
OK, so posts that include context for IPIX discussion conclusions, where the original inquiry contains false assertions that are subsequently refuted, would cause the loss of context. Aha, now I get it. An Orwellian IPIX situation, that is.
It’s in trial until the data is locked. The data isn’t locked until there is nothing more to input. Unblinding does not take place until after data lock.
Double and triple checking outcome measures delays data lock because once locked no data can change in any way. There is most likely a trial audit underway to confirm all data points from over 30 clinical sites. That means actually visiting the sites to assess data collected and procedures followed for the protocol.
CEOs of biopharmas never discuss this, at least in my 20 years experience I’ve never run across a CEO who presented anything but final outcomes. Company officials can’t even include any data prior to lock (and unblinding) at conferences due to rules against presentations for drug outcomes of drug trials still underway, meaning prior to data lock.
That’s just the way it is.
Why not compile the replies and post that? To stickie the inquiry is misleading.
Why is an inquiry about IPIX, s-3, and funding limits with flawed information, as of yet, still a sticky note? This stickie does everyone a disservice, including its author.
If one bothered to read regulatory and FDA guidance one would know this shit. In fact, many of us have provided the same but “we” chose instead to ignore it. CEOs in biopharma are not responsible for the willful ignorance of investors.
Why does the CEO have to speak about things that are regulatory and every investor should already know before they get into high risk investing?
Yes, but I didn’t want to say that.
Wrong! Good results will fuel speculation on an impending deal for Prurisol. That’s what we are waiting for. Anything that beats Otezla (or whatever that crap is) will immediately make Prurisol a pending blockbuster. The mar will react stronger than 50%. It will be more like a return to $1.17.
It’s not “floundering.” All 7 drugs are moving forward. There are 5 recent trials that recently completed, so IPIX is between trials. The next round of trials are getting worked through proposals as well as FDA feedback and responses. Management still has plenty of low dilution funding options available, if there is no license, but there will be one soon.
Like boodog, I’m putting my pocket book where my keyboard is: I’m still buying because I know why I’ve continued to buy and hold for months. Anything under $1 will be seen as a huge bargain very, very soon.
I didn’t mean to insinuate anyone should be happy. But, I do mean to agree with your implication that 130 days in biopharma testing is rather short term for results and outcomes data (not implied by you: when looking at from 1 year up to 3 years between trials. 3 years from one trial to the next is not at all unusual).
You sure you don’t mean “alimentary”? Seems like a legitimate, possibly even a good, question that someone with a little knowledge could easily answer with just a tad more detail.
The weightloss has nothing to do with IPIX share price. In fact, as the price has declined, I’m overweight in shares (which I consider a good thing).