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Perhaps he has agreed to behave in this manner...
IMO, there was a definitive shift in IPIX's communication strategy with respect to Prurisol in the June-July-ish timeframe. The last P blog was on 6/8. Since last summer we've received only perfunctory trail progress and data release updates.
Leo essentially went dark on P last summer...doubt we hear anything until the data is released.
Absolutely. With a P deal in pocket, Leo will no longer be the skinny hyena at a water buffalo kill. He'll be able to put up a much better fight against BP negotiators who will no doubt whittle away at, carve up, and carve out value that Leo will want for IPIX.
I don't expect a B deal to close unless one of the following events occurs:
1) P results disappoint
2) a potential partner brings something absolutely critical (other than cash) to B's further development
3) BP rings the bell at Leo's numbers
When IPIX adopted their value maximization strategy a couple of years ago, I think it was fairly obvious that the intent was to partner with P first, if possible. They had not even started the B-UP trial at that point in time. Business conditions have changed since then, as they always do, and timing of all the trial data has made the potential for a B deal a viable possibility; however I haven't seen anything happen as yet that would necessitate a modification of their original plans.
I think Leo's strategy is simple at the moment. His numbers right now for anything B-related are high...quite high. He moves all options forward as much as he can but doesn't decide on a definitive path forward until he is certain of the P results. If they're good and he deems a P deal likely, he'll pursue that route rather quickly. It's likely he has a few players lined up for a fast look and decision on the data. If P disappoints, he'll drop his numbers for B, and get something done with that asset.
I certainly can't cite any PRs but my take on the issue is that the extra patients resulted from a final, mad screening scramble to make sure that enough (>= 189) participants were in the trial by the end of August, thus guaranteeing an end of December, end of Q4, on-time trial completion.
Given mgmt's defensive handling of the ostensibly benign interim report cancellation, there's no way in Hades that Leo wanted to announce to the market a trial delay from Q4 to 1Q18...no way, no how.
Rest assured, if we do indeed see another Chatty Cathy PR about partnerships, CDAs, group hugs, and friendship rings with respect to B, we're not much further along in the process than before. Complete and utter silence is the professional, operative norm when talks are truly serious.
A Derm company ??? You mean something like Innovation Dermatologics ??? I wonder if such an entity exists...
I don't think the K trial is ending anytime soon. It's difficult to recruit and very complex in it's data collection and analysis. Besides, I don't think the main goal of a K partnership is to get a lot of up-front money on a deal. It'd be nice if it happened but I think IPIX really wants someone to pay for the long, expensive oncology trials, and to be able to tap into some BP cancer expertise for further development.
Absolutely 68, i agree 100%. I think Leo has some monster, monster numbers in his mind for the valuation of B, and I'm not certain BP is at that level yet. With a sizable payday from a P partnership or sale, he can further develop B to push it the valuation curve until he gets what he wants.
Not only logical, but fiscally prudent as well, no? P is a potential major asset to the company, so why would LE not want to know whether it is part of the future before deciding on a forward business strategy?
Agree as well. Good board. Appreciate the no-nonsense, objective discussions here....rare within the message board universe.
Agree. I think the likely scenario is that the company was trying very hard to meet their EOY milestone for trial completion. Since it was getting down to the wire for doing so, I'd bet all active sites where in "get what you can" mode to ensure they would not come up short at the end of August.
agree there frrol...appreciate your thoughts
Well that's just it, I think they've already messaged the cancellation by way of Leo's email response to an investor.
You think that was an accidental slip-up prior to quarter-end, or prior to some other planned form of communication?
I just wonder how much of their response is reflexively defensive. Can understand the mentality as "the market" has unethically and viciously hammered the company over the past several years.
But these guys are on a roll. There's no reason to cower. Time to change the mindset.
Question for you frrol: Why do you think the company chose their particular strategy to inform the market about their decision not to provide an interim analysis?
Leo and Dr. B are intelligent individuals and were very aware that they created a data release expectation within the market, and would have to somehow communicate its abandonment. They most certainly discussed information dissemination strategy.
Dr. B's recent presentation provided a perfect venue to use a direct approach. In discussing the P trial (which he did), Dr. B could have addressed the issue with a succinct comment or two to the entire investor community, about their decision and reasons behind it and moved on. Then follow up with a blog post containing more information about investigator bias in clinical trials. Done. Over.
Instead they chose to employ classic damage control methodology (which all companies and CEO's do) in choosing not tackle the issue head on; rather to leak the information quietly via an email response knowing it would be posted to iHub, and following up with a throw-down PR as a diversionary measure.
The thought here is by addressing the issue in direct fashion now they would draw unnecessary attention to it and make it into a bigger deal than what it truly is. Now that they've "softened the blow", they'll come back at a later date with more explanation and proclaim "no big deal".
They used the same tactic back in the spring to announce the P trial delay, which IMO is a much bigger deal in terms of financial risk to the company than whether or not interim data is released. It didn't work too well then. I am not a big fan of the strategy, particularly as an automatic response to non-positive news.
Unfortunately, it seems as though they've added a lot of unnecessary stink to the situation which could have been diffused rather easily and in a much more credible manner.
Agree with your line of reasoning here SS.
Have thought from the get-go that the timing of the interim analysis, at a point when most of the trial is complete, was odd; so have always been curious as to its intent.
If the interim thinking was to "look for a signal", they may very well have their signal via the unblinded data to-date and have forgone the intermediate analysis for integrity reasons as claimed. This IS the money trial for P. Might be just as simple as that.
True. Ostensibly we're getting a 6 week readout of some sort for interim data. If it's blinded then what I've posited is meaningless. I think we'll see unblinded 6 week data, the purpose of the unblinding to give the 12 and 16 week data to BP under the auspices of confidentiality.
If the interim were purely for investors, I think we would have seen data long ago.
And what exactly constitutes "enough data" for the interim?
Yes, I'm suggesting that on March 21st, from the PR announcing B-UP cohort 2 interim results, where Leo stated:
"The Company looks forward to continuing to share results with investors and the public across the coming months and will be presenting topline findings at the 2017 Drug Discovery and Therapy World Congress to be held July 10-13, 2017 in Boston."
that he did not have cohort 3 results as yet. They had planned on presenting at the conference for months prior. But keep trying...
Yes it is. I think the entire purpose of the back-ended interim is to transfer as much data as possible to interested counterparties so that they can begin their own internal evaluation processes (modeling, scenario analysis, DD, discussions, etc.) for either partnership or asset purchase.
Numbers matter as there is currently a very wide range of valuations based on drug efficacy, so the more certainty in the data, the better to narrow down what the asset is truly worth. Agree with Sox that 100% is best, but due to the trial's recruitment issues, they will probably back off that target a bit to ensure a Q3 release.
Given the back-ended structure of the interim, certainty is exactly what I think they're after with the release, as it gives them a 3-4 month head start prior to topline data in knowing what they've got, and therefore how to proceed.
For example, if 90% of the overall data are collected at the interim and the 6-week result shows a 20% PASI-75 response, they'll know that the topline 6-week result will be between 18% and 28% (neglecting dropout considerations); numbers that will give them a pretty good idea of where they stand.
Furthermore, if they are opening the book (unblinding), I don't they they stop reading at chapter 6 without also taking a peek at chapters 12 and 16. If the data is positive I think it will be shared with those parties under a CDA to get some other things moving along.
Totally agree with you there :)
The folks below like the rigor for comfort, security and back-up, but pitch it to everyone above with crayons, etch-a-sketches, and lego bricks.
You've highlighted additional sources of uncertainty imbedded within the overall valuation, and agree that they can be, and are generally, rolled into a single discount factor used by dealmakers. However the assessment of risk can be broken down (and sometime does) into a rather complex mathematical treatment of the various factors comprising the aggregate.
As someone who has provided analytic support to asset valuations on both sides of deals, I have in some cases engaged in these types of analyses. On the other side of the spectrum, I've also practiced the fine art of anal extraction to arrive at a discount for risk. In the end though, the dealmakers tend to have a single "haircut" number in mind and work from there.
As the future cash flows are currently uncertain, I'd also like to see the methodology for the quantification of the aggregate risk in obtaining those cash flows, in order to properly discount the valuation for the fact that they do not exist.
Don't know what your definition of "minimum effect" happens to be, but sure there will be some sort of sell-off if P misses....only natural.
However, based on the B results to-date, the market will find support from buyers who chose not to wear full or partial risk of the interim P event and will either initiate or add to a position solely based on the outlook for B.
I think the collective market is 50/50 on the outcome of the trial, which given the way it tends to assign risk, is a pretty fair assessment of the ph2a data.
Anyone who desires long exposure to the interim data release is already in the market and positioned for the event. Just a waiting game for now.
Slow bleed down on extremely low to nonexistent volume is from the random selling that occurs every day for various reasons.
I'll be more than happy to shoulder the burden of raw data extrapolation. Although only a 6-wk readout has been promised, how about providing the following interim dataset:
1) 6-wk PASI-75 score on 90+% (170+) of the patients
2) 12-wk PASI-75 score on 50% (or whatever) of those patients that have completed at least 12 weeks of treatment
3) 6-wk PASI-75 score on the 12-wk subset of patients corresponding to item #2
Would love to do some further ciphering on those results....
No sir. After completing the current powered ph2b trial, fruit on the P-tree will be just perfect for value maximization selection. Fruit on the B-tree, while needing some more vine time to increase its value, could be picked a little early if need be. And fruit on the K-tree....well we'll get a better idea of its ripeness when we get some info on the ph2a trial.
All is well in the IPIX orchard.
Exactly. Even if Leo torched every bit of a Celgene bridge to the ground, they could still shuttle a large check across the river by canoe to purchase the entire asset. Leo could send an intern to pick it up.
Ah good catch F1...my bad. Shouldn't have trusted my memory...
So our overall drug:placebo ratio is 108/189 = 57%
Good example though of the trial recruitment competition that we've been up against.
Here's the flyer for the trial:
Tampa PsO Flyer
Similar inclusion criteria. In addition, our drug to placebo ratio (n=189...81/81/27) is 162/189 = 86% and their 7 out of 8 reference is of course 87.5%. Dead on.
The more the better. Wait another month and get to a >90% majority.
Agree.
KMBJN, thanks for your objective contributions to the board.
To paraphrase Leo...."yes, yes, and yes"...
Depends upon the intent of the interim.
If the sole purpose is to release data to the market ASAP, we could see something fairly soon.
If a goal of the release is to maximize the number of subjects so as to minimize any potential discrepancy between interim and topline numbers, then I think we'll see a Sept release.
Yep...100% agree. With 189 patients, a placebo arm, and at a 2b stage corroborating 2a results, this is a BP-friendly trial in a hot market with an extremely valuable asset.
For now, it's the money trial.