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Not sure to what the "that" in your question refers...
Interim P release will be significant for several reasons. Currently, the market for IPIX is both short-term oriented and risk averse. The end of the year is WAY down the road on it's calendar.
And to be clear, I'm speaking of market significance as distinct from asset value. The topline B-UP results increased the value of the B franchise, but given IPIX's current position, was never going to move the market cap (SP) to a large extent.
FINALLY...the runway is now clear for takeoff.
In terms of potential impact on the market, the interim P release dwarfs by a long shot any and all of the B data events over the past 9 months. And Monday opens the true window for a Q3 event as nothing was going to happen with P prior to the conference.
Sorry B fans, it is what it is. Not all trials are created equally. The rectum will have it's day, but not for awhile. And on that day there WILL be joy in Mudville.
For a number of reasons we are going to see a completely different market response, including volume in the millions, on the day the ph2b data is made known to the public.
Incorrect.
The real news of trial results was released on June 26. Volume was over 700K that day...doubt we get there today but it's not over yet.
Subsequent to that news the market rallied 30 cents from 0.70 to $1, with follow-thru of an additional 4 cents (so far) today.
I hate to use percentages at these levels because pennies, nickels, and dimes are just noise IMO, but for comparison to your numbers:
34/70 = 49% which is > 15-25%
The market has reacted positively to the data.
Data as expected yesterday = flat (so far) day today
Ummm...what exactly was unexpected in the results today? I didn't see any surprises, either positive or negative. The only key piece of information that we didn't know 2 weeks ago is the absorption rate in cohort C.
In rallying from 0.70 to long-term resistance/support in the $1 area, the market DID respond favorably to the B-UP data release, upon June 26th news of reaching the end-of-trial milestone and a read-between-the-lines confirmation of positive cohort C data.
Unless something completely unexpected appears in the presentation data, I don't think we're going to experience Big Bang Thursday.
Yes, you had an excellent post detailing how we know this information; referenced here:
#188666
Given the small sample size I don't see a significant difference between 3 and 5, but hey, if IPIX gets to $5 by July as some have predicted (not you), I'll gladly raise a glass of something potent in their honor.
Yes...and we already know that it's good. There's not much uncertainty left.
Perhaps my larger point is to not be disappointed if the market doesn't explode, launch, rocket, blow-up, etc. subsequent to the data release this Thursday. If it doesn't, the reason won't be because Leo is Satan incarnate, nor attributable to people trading without their clothes on.
Even if results are spectacular I don't believe a deal for B will be imminent.
Leo has intimated that there is a potential premium (value in excess of sum of parts) associated with a platform deal. So why would he risk eroding potential value (i.e. not maximizing it) by carving out a separate B-UP deal, when it's absolutely unnecessary at this point in time. If P data is good, he does that deal. It will be quick and easy.
I think there's a reasonable chance that we've already experienced the majority of the market's reaction to Thursday's data release. Personally I don't expect significant SP appreciation on July 13 unless either of the 2 following events transpire on that day:
1) interim P results are released
2) Endoscopic vids reveal remnants of signed BP/IPIX deal paperwork that someone had to swallow for confidentiality reasons
Other than that, the PR announcing the end of the trial and release of the conference abstract removed just about all vestiges of doubt in the quality of Thursday's data. The market was happy, it made its move, and will now prep for the P trial data.
You're welcome. Agree that the RHS of the final distribution of moderate patients is very encouraging; the LHS not so much.
I did this quite some time ago and used IPIX's Sept '16 presentations as a basis. The logic may have been something like this:
We know that they reported on 20 pts in the PP group and that 35% (combined) had a >= 2pt IGA reduction...so that's 7 pts overall.
We also know that 46.2% (glad they added the 0.2 !!!) of pts with baseline IGA 3 ended up as meeting primary endpoint. Knowing that they started with a 2:1 split in the combined group it wasn't hard to come up with the ratio 6/13, by trial and error, as the fractional representation of 46.2%.
So 6 IGA 3 responders and 1 IGA 2 responder constitute the 7/20 overall result.
From there one can view the presentation charts to determine the final distributions. For example, there is a 15% result for IGA 0 in the final set. 15% is 3/20. We know 1 of these is from the mild group (its single >= 2pt responder) and therefore 2 are from the moderate sub-group.
and on and on...
There might be another piece of data that I used from somewhere, but I think you get the idea...
Honestly, I'd have to back and refigure out how I figured it out in the first place, but part of the exercise was manipulating numerators and denominators to match published ratios, as well as invoking logic such as the only way for a baseline IGA 2 patient to be counted as meeting the primary endpoint would be to end up at IGA 0.
In a response to your other post I outlined the final outcome distributions that should be consistent with published results. I think the only derivational assumption that I made was that no baseline IGA 2 ended up as an IGA 3; a supposition that I've not been able to confirm from any IPIX release.
The 20 you cite is combined and includes 13 patients who initiated at IGA 3 and 7 patients at IGA 2.
2 of the moderate patients had a final IGA score of 0....2/13 = 15% PASI 100.
While carving up IPIX by asset is a clean and "easy" process, management is most certainly contemplating division by indication as well. My guess is that Dr. B, being a derma guy, would find the building of a dermatological juggernaut to be a particularly enticing avenue to tread. Combine topical B as a potential treatment of acne, etc. with P and its possible treatments and you've got some serious derma horsepower.
While probably not a predictor of events to come in the short-term, I do think management is planning, as good business leaders do, for future growth and expansion. IPIX has potentially 3 MAJOR assets on their hands, and therefore also possess many, many options on how to progress and develop the company.
I'm sure Leo and Art have quite a few things in mind for the future and want to keep their options open at this point, so I don't think the name "Innovation" was a casual choice. Art owns the entity "Innovation Dermatologics" and it could easily be restructured in the future to fit their needs.
But who knows, maybe we see a JV with P right out of the gate?
Yes, that's quite a few dropouts and is one of the issues with the quality of data in the study; adding some additional uncertainty to the overall results.
5 dropouts were moderate and 2 were mild.
There were dropouts. They reported on 20 patients; 13 moderate and 7 mild. 46% represents 6/13 in the moderate arm.
Nice synopsis on your prior post....thanks biodoc.
The 20% PASI 75 at the 6-week interval is the exact number I had in my head for a very favorable interim result.
I agree with the assertion made by others on the board that the back-ended interim look will be used to initiate the serious phase of deal negotiations; i.e time for potential counterparties to sharpen their numbers and IPIX to gauge who indeed is seriously interested in a partnership.
I think Leo is using the interim to expedite the deal-making process. Get data in front of BP ASAP.
I think the Otezla clinical comps mentioned below are a bit overcooked. Perhaps I am misunderstanding the intent of your post, but if we hit 30% PASI 75 at week 6, then our 12-week read-out will destroy O's numbers.
See IPIX's Sept 9, 2016 slide deck page 14 for a graphical representation of one of the Otezla studies. Their 6-week results are about 12% PASI 75 and 2% PASI 90. These numbers should be the comps for O equivalency if the P interim results are indeed reported at the 6 week mark. And yes, agree that we a looking for a faster uptake and therefore higher numbers at this point in the study.
IIRC, there were subsequent O studies which demonstrated better long term (16 week) results than the one referenced in the presentation. I'd have to dig to see if there are intermediate data available, but I don't expect anything drastically different from mid teens for PASI 75 and low single digits for PASI 90 for 6-week results.
Yes, I think most are expecting additional B-OM data in the July release. The source of this expectation is from a statement issued by the company that I personally find ambiguous as to whether there will be an additional unblinding for the July presentation.
As such my own expectation is for there to be none other than the 19, and will be pleased if we do indeed receive new data.
I expect the July B data release to be a yawner as far as the market is concerned because the results are not likely to resolve a great deal of uncertainty.
Contrast that to the interim P release whereby the possible outcome ranges from failure to biologic efficacy for a safe, oral psoriasis drug. That's a vast chasm of uncertainty to eliminate.
The interim P data is THE most significant market catalyst over the past year. Trial specifics matter and this one is much more robust than anything presented in July. It's a phase 2b, double-blinded, placebo-controlled effort with a significant number of patients. Given the 505b2 designation and probable low N for the phase 3 trial, the ph2b results will be an excellent predictor of ph3 success.
In the near term, the P trial is a big deal.
Actually, because of the encouraging data to-date and therefore the promise of the B franchise, more risk-adverse B-only investors (and perhaps others) will employ your exact strategy, in not desiring to wear exposure to the P data release. It's a simple case of managing risk.
If the P trial fails I don't expect the subsequent dip in SP to be as ugly as you suggest because the value of the B asset will provide market support at a reasonable level. In terms of percentages though, there could be a significant initial plunge in SP to buy into if P results don't meet efficacy goals.
IMO it's fair to say too that the ph2a dataset, in its entirety, is not the squeakiest of clean; meaning that there is some considerable uncertainty not only as to its own outcome but also as a predictor of the ph2b outcome.
I think that the odds favor positive 2b results, particularly given the dose escalating arms; however anyone (not you specifically) that promotes and/or believes that the ph2b trial is accompanied by 0% risk is simply foolish.
Ok thanks. I inferred that the "additional" in the statement you referenced applied to information pertaining to patients in the preliminary report, meaning we were going to get more detail on the 19 than what has been reported. But I can certainly see how it can be interpreted to mean the inclusion of more patients.
36 patients???
This is a blinded trial with a placebo arm and we have interim results already. Is the expectation that an additional unblinding will occur??? Did I miss an announcement stating so?
July, July. I don't quite get the board's frothy exuberance for the month of July, and in particular the Boston conference. What is it about the "big data reveal" at this event that will provide any significant amount of info in addition to what we already know and expect?
Cohorts 1 & 2 for B-UP demonstrated very positive results for safety, efficacy, and low systemic absorption; and even showed a slight hint of dose-dependency. Is that not the expected outcome for cohort 3?
Interim data for B-OM will also be presented. We already know of those results as well.
In short, PR and more eyeballs will be a favorable outcome, but, as opposed to the P-trial data release, the conference will not resolve any great uncertainties and therefore I don't expect it to be a significant market-moving event. What am I missing here?
Yep, absolutely. In fact if Leo's value maximization strategy plays out as planned, I anticipate a K deal long before a B deal; contingent of course on positive P results. Getting a P deal done with a sizable up-front payment will allow Leo to progress the B platform forward and give BP time to move in the direction his desired number for a satisfactory deal.
The scientific skepticism on previous CTIX data has been whether K actually does modulate p53. The intent of the current K-OC trial, in combination with related murine studies, is to unequivocally prove that K modulates p53 in a productive manner, as Dr. B has stated.
If they're able to accomplish that to the satisfaction of BP entities who no-doubt contributed to the trial design, a partnership will ensue.
Correct on your assertion about no significant (meaning multi-dollar) rise until a deal is reached, but incorrect as to the reason. The market will want to see the size of the upfront cash payment from the deal so as to be confident that there will be no need for further persistent dilution.
Don't think management credibility is the issue now. The market all about results from P trial, the completion of which is CTIX's first shot at a legitimate deal. The ph2b is a robust trial with a significant number of patients, and if data is positive and clean, will serve as an excellent barometer for ph3 results.
One of the characteristics of a persistent bear market, as is CTIX's current state, is that buyers will tend to wait, thinking/hoping that they can get in at cheaper prices because there's no real urgent need to buy. As buyers wait prices drift lower.
Positive P trial data is the factor necessary to change current market psychology.
The FOY and 4/20 estimate for K trial completion was 2H17. In the 5/3 CTIX blog post, a refinement of the window to 4Q17, the later half of the original interval, was communicated. I'm not expecting any information soon.
There's also a fairly wide range in the asset's potential valuation pending how well results compare to Otezla, and possibly to biologics. Quality of the trial data will determine the specific deal numbers.
The market was going to sell off yesterday based on the P trial timeline revision alone; regardless as to the reason why, regardless of the CEO, and regardless of his credibility.
And once support is broken, as it was yesterday, all bets are off as to where the resultant volatility will carry the SP.
There's an easy answer to your question that should be even more clear given recent events. The market is currently short-term oriented and wants to know the manner in which CTIX is going to fund the future development of its 3 drugs.
Management's strategy for the past year has been to get to a partnership in the fastest means possible while maintaining a goal of maximizing asset value. Since deals will not be consummated until trials results are completed for analysis, the P trial is the current mechanism to get to a deal the quickest and therefore it's the market's focus. Both K and B trials do not project to complete until EOY.
Because the time estimate for interim P results was pushed out from 1H to 3Q, the market, with its focus solely on this trial, sold off. The drop was not due to a rehash of B information.
Truth.
There were visions of data releases and deals amidst swarms of sugar plums dancing through some heads in response to the statement. Sometimes a reality check is painful.