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Skweze-- When the 2nd line lung data was unblinded and released in early Sept, there was a 99% likelihood there would not be a subsequent event (i.e. discovery of a CSM error) that canceled the favorable impact of this news. Yet that 1% chance of a screw up by CSM did occur and a half dozen law firms have now filed claims based on the theory that it was negligent and misleading for PPHM to release the data when they knew there was still a chance this subsequent event might occur. The core of their argument is that the data was released prematurely.
The Company is in exactly the same Catch 22 today. The reconstructed data may be excellent. The MOS may be even better (i.e. more “material”) now than it was before. But if the Company releases the revalidated data before it has been accepted by the FDA, the same lawyers will double up their claims, saying that the Company should have anticipated a subsequent FDA event that could cancel out the favorable impact of the reconstructed data.
I don’t give the current class action lawsuits any credibility because the likelihood of the subsequent event happening (i.e. discovery of a CSM error) was probably under 1%. The CSM screw up was not “reasonably foreseeable” by PPHM. That is why the Company has no liability for what happened.
However, the possibility that the FDA might reject the reconstructed data, even if it is excellent, is indeed “reasonably foreseeable” by PPHM management. The class action lawyers would have a much better claim this second time around if the reconstructed data is announced before the Company knows how the FDA will view it.
HonestAbe-- You make a good point. I have two thoughts in response:
(1) if the reconstructed data is good but the FDA takes the position that they won't accept it for Ph III planning purposes, then the re-validated data isn't really that "material" after all. The definition of "materiality" is "likely to cause a reasonable person to buy or sell the stock." If new data is good but Phase IIb has to be repeated, the good news and the bad news cancel each other out and it's not at all clear that you have a "material" event. However, if you defer the PR until the FDA has said how they will treat the reconstructed data, then you clearly and truly have material info.
(2) I suspect Company counsel has already consulted with the SEC on this issue. I suspect the SEC would prefer to see no news for another 3 weeks than to see the stock run up on the PR of the re-validated data and then run down on learning the FDA is requiring Ph IIb to be repeated notwithstanding the good data. Such an FDA determination would cast yet another shadow on the data. Far better to wait and release all sides of this story at one time.
Here are my thoughts about the “weeks not months” statement I received by email from PR on the morning of Sept 24. The statement said that the Company “anticipates having results from the investigation in weeks not months.”
Since that email on Sept 24, all of my multiple attempts to communicate with PR by voice mail and email have been politely deflected pending conclusion of the investigation. So the comments below are my personal conjecture only.
IMO, the Company did in fact obtain “results” from the data re-construction process in a matter of weeks. I believe that by Oct 18, the date of the ASM, the Company already knew the general outcome of the effort to re-validate the data. That’s why Dr. Garnick was able to say at the ASM: “This is just a bump in the road.” I can’t imagine him saying that if he didn’t already know the key results of the error-correction process.
“Having results” from the data re-construction process and being able to talk about those results are two very different matters. This is true for four separate reasons:
1. The CRO that screwed up was licensed / certified by the FDA. How PPHM talks about this screw-up has huge implications for the FDA’s double-blinding process as a regulatory matter affecting all trials. If this type of mistake could happen so easily, maybe the FDA has to issue new rules regarding the double blinding process. To stay on the FDA’s good side and not blow that critical relationship, anything PPHM says in a PR or a CC about what happened and who screwed up has to be pre-cleared with the FDA.
2. As a practical matter, it doesn’t do the Company much good to announce the results of the data validation process if it cannot also speak at the same time about the FDA’s willingness to accept the reconstructed data for Phase III planning purposes. IMO, the Company right now is going back and forth with the FDA in a quasi-EOP2 process to determine the extent to which the FDA will accept the reconstructed data for Phase III planning purposes. What good would a PR be that doesn’t address this point? Obviously the FDA’s willingness to accept the reconstructed data and move Bavi into Phase III will be impacted not only by the scope and independence of the validation process but also by the strength of the data itself, i.e. how strong is Bavi’s MOS in 2nd line? How good was Bavi’s safety profile in this study? That’s why I think the Company must be going through a sort of preliminary EOP2 meeting process with the FDA right now.
3. As a legal matter, additional time is needed to complete liability negotiations with the CRO that screwed up and its insurance company. For example, the CRO and its insurance carrier may be willing to pay $1X million in damages if PPHM serves the complaint and publicly denounces the CRO’s negligent conduct, but would be willing to pay $3X million if the PR does not publicly lay the blame on the CRO and ruin their reputation. Also, obtaining an “indemnification and hold harmless” covenant from the CRO and its insurance carrier regarding the pending class actions securities litigation is another variable in these negotiations that has to be finalized before the lawyers can determine how to craft the wording of the PR.
4. Finally, the BP who was about the get two seats on the PPHM Board before this mess happended has to be consulted with, and their concurrence obtained, on all of the above issues.
Bottom Line: There is a HUGE difference between the time when the Company “has results” from the data reconstruction process and the time when all parties are ready to put out a public statement that has huge regulatory and legal implications.
How much longer could it take to work out all these issues with all these players? Since the Company is managed by scientists who care most of all about how they are viewed by the medical and scientific communities, IMO SK will pull every lever he can to get this wrapped up, and a PR issued, by the time of the Thorpe and Shan presentations at the IBC Antibody Conference on Dec 5, 2012.
Ridiculous ! They never said any such thing. Source please.
The test for insider trading is based on the reasonable man standard; no "guarantee" of going up or down is required.
The test is whether a reasonable man who had the same "material, non-public" information as the BP would be likely to buy or sell the stock in question if he had had the same non-public information.
So here is the test: If an ordinary investor like you or me had signed an NDA and learned in early Sept. how many stage IV NSCLC patients were still alive 13 months after dosing, and how healthy they still were in mid-Sept., and how well Bavi is doing in the related pancreatic and liver trials, would that information be likely to induce us to buy the stock after it fell it $0.84 on news that there had been a coding error in the investigational drug treatment groups?
If the answer is "yes", if knowing confidential, non-public clinical details of how well Bavi was performing in mid Sept in multiple contexts, would be meaningful to a reasonable man's decision to buy the stock when it fell by 80%, then there is a legal basis for an insider trading lawsuit.
Will we see 13Ds filed by BPs who did partnership due diligence on PPHM ? I don’t think so. The risk is great that they are in possession of “material non-public information" as a result of having done extensive due diligence on the Company’s clinical data in preparation for a partnership deal.
Even though the Sept 24 PR created a level playing field regarding the coding error, a BP who previously signed an NDA and evaluated important MOS clinical details that retail investors have not seen-- like how many patients are still alive and how healthy they are-- would have a huge advantage over the rest of us in determining that the 09.24 PR was a minor hiccup on what is otherwise an outstanding Bavi performance.
Any BP who bought on Sept 24, 25 and 26 based on Bavi clinical confidences they gained during a prior, confidential due diligence process would not only be trading on inside information, but would also, as a practical matter, anger PPHM management and jeopardize their chance of being the chosen bride.
I believe the Company and its new BP partner could sue the BP partner who accumulated shares based on a violation of trust and get the court to compel a disgorgement of those shares.
The class action suit against PPHM is going nowhere. It was obvious this was coming-- so I spoke yesterday at length with a securities litigation attorney. Here’s what he said.
Plaintiff’s counsel are up against a major hurdle because the securities laws impose a huge duty on companies to disclose material information as soon as it is available. The highly material interim data from the Ph IIb NSCLC trial became available approx. Sept 6 and the Company disclosed it the next day, on Sept 7, as they were obligated to do.
When market-moving information becomes available, even if it’s only “interim” data, a biotech is required by the SEC to release it right away. The notion that the Company could have sat on this independently verified, market-moving data for two weeks (i.e. from Sept 7 to Sept 21) while the Company did its own double check of the data for a different FDA purpose is ludicrous and would create an enormous loophole for leaks and insider trading.
Imagine how crazy SEC disclosure policy would become if each company could decide how much time it needed to do its own double checking of market-moving data received from authorized third parties. Some companies would take weeks, others would take months before deciding to scrub the data in connection with their EOP2 meeting prep.
Even though plaintiff’s counsel don’t have a legal leg to stand on, high profile lawsuits are often filed in the hope of getting a nuisance settlement. I don’t see how that tactic could work here since it will be easy for PPHM to get advisory opinions from the SEC and FDA that companies must release material interim data received from authorized third parties as soon as it is received. Any other conclusion would wreak havoc on the core principles of securities law disclosure and open a loophole for leaks and insider trading large enough to drive a truck through.
Moreover, if you re-read the Sept 7 PR, you will see that the Company repeatedly put investors on notice that this was non-final “interim” data. Investors were on notice.
This lawsuit is a joke.
Thanks GG. Very well-reasoned article. The author writes:
"Although it's conceivably possible that the real placebo group could have fared better than the non-placebo group, that's the least likely outcome here, given bavituximab's history. Errantly mingling of the testing samples, if anything, should have caused more homogenous results for both groups rather than a group with distinctly different results. Given the error in question, it's actually possible that un-mingling the results could show that bavituximab is even more effective than first thought."
I asked PR if they could provide internet sources on how the double-blinding process works with Third Party Vendors and how the “independence” of that process is verified.
I received a response which I paraphrase as follows:
1. At this time the Company is not making any public statements beyond what was said in the PR this morning.
2. There is an active investigation going on right now that involves an external body, and
3. The Company anticipates having results from the investigation in weeks rather than months.
There are only two choices to explain the exceptional number of very sick Stage IV patients who are still alive today: if the ones who are still living today--- on average 14 months after dosing--- did not receive Bavi, then they received the control group drug, i.e. Docetaxel plus a placebo.
The mean MOS for Docetaxel alone as a control drug in 12 separate historical trials in second line NSCLC is 7.4 months. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=76905176
So right now I have a choice between believing a new drug called Bavi doubled the MOS in these patients, or an old drug called Docetaxel doubled the efficacy it showed in 12 prior trials of second-line NSCLC patients.
Hopefully the mix-up will turn out to be between only the patients who received the 1mg dose and the 3mg dose of Bavi.
Regardless of where the mix-up occurred, this is going to cause huge consternation and embarrassment to the FDA and the entire Phase III drug approval process which depends on exactly the same double-blind, independent monitoring committee gold standard that was used in this Bavi NSCLC trial.
This screw up by the double-blinding agency (which I believe is accredited by the FDA) will give Peregrine months and months of major publicity for years to come as the entire Phase III gold standard drug approval process comes under scrutiny.
Given how disruptive the Bavi anti-PS platform is to the entire pharmaceutical industry, one has to wonder if this never-before screw up by the FDA’s double-blinding agency was intentionally arranged by a BP. Yes, for the first time I am considering there may be a BP conspiracy at the bottom of this debacle.
Rational thinking tells me it is far more likely that it is the novel MOA of Bavi, and not some unprecedented Docetaxel anomaly, that is causing these Stage IV NSCLC patients to live twice as long as ever before.
This week portfolio managers from all the large NYC Health Care Funds are scheduling one-to-one meetings with SK and his team at the Credit Suisse conference on Friday of next week.
You can bet your bottom dollar those Fund managers will come away from those meetings with a really good idea as to which BPs are on SK's partnership short list and the basic outline of deal terms and time-to-closing for those negotiations.
And none of what the Funds are told next Friday can be called "inside information" because SK already gave the public an outline of the same information as summarized in my Post 91553 (Parnership timing), Post 91555 (outline of the key BP deal terms) and Post 91557 (Garnick's explanation of why SK is in charge of the BP negotiations).
It's not SK's fault if the public is too slow to figure out what he said in Monday's CC. Basically, he told us in multiple ways that the BP negotiations are at a very advanced stage and Peregrine is in charge of both the deal timing and many of the deal terms. Once having disclosed these facts publicly, SK is free to engage in more detailed discussions of the same topics with Wall Street Fund managers.
As SK said in the CC, "there's been quite a number of good comparables out there for deals recently." For example, all you have to do is take the PCYC deal closed in Dec 2011 (traditional royalty for Ex-US territories plus co-development rights in the US) and then multiply PCYC's $150 million upfront payment by 2X or 3X to account for the "data clarity" and "straightforward approval process" that Garnick explained (see post 91557), and you can see that you and I already know everything that will be confirmed to the Fund managers next Friday ! [... less only the wink and the smile that the Goldman Sachs team will see.]
:) :) :)
Comment #3 from Transcript: Garnick tells us why SK is in control of BP negotiation:
Comment #2 from Transcript- Key BP Negotiating Terms are Outlined:
Comment #1 from Transcript- Early BP Partnership confirmed:
jbainseky-- I think you will be surprised when you read the transcript of the call. SK was very specific that there was a "big advantage" to be realized from having the BP on board before the EOP2 meeting due to "global registration" nature of the Ph III trial.
Moreover, you don't volunteer information about the size of the upfront payment you could receive from US co-promotion rights, and how that is a variable you are reviewing, unless you are very far along in your negotiations and very confident you know you have data now that allows you to dictate the terms.
The BPs we are talking with listen to these calls. Unless you are sure you can call the shots, talking the way SK talked would come across as very arrogant.
JR- Good point. There was an oncology deal announced recently with Ex-US rights plus co-promotion in US. I think the upfront amount paid was $150 million. I thought I printed the PR but I can't seem to find it. My recollection from quick look was that the drug was not a wide-scope platform technology like anti-PS, and the Ph II trial was not blinded, but this has to be confirmed
To my surprise, no one asked directly about AA and the company did not volunteer that info.
Agreed-- Indeed lots of clues that BP partnership is very close:
First, the detail was very specific about the "big advantage" from having BP on board before EOP2 meeting so that distribution of the 400 patients in Ph III could be matched to the marketing priorities of our new BP partner. For example, if Sanofi based in France is our partner, they will want to have more European patients. SK emphasized the Ph III trial will be a "global registration" trial, so you need to pick you BP partner in the next several weeks to be ready for an EOP2 meeting in Nov or early Dec. before the holidays.
Second, SK sounded much more confident this time that he could pull off a BP deal that is primarily, or exclusively, Ex-US. He made it quite clear that the only reason he would tack on a co-promotion deal in the U.S. is because a deal which is only Ex-US may not bring in enough upfront funding to launch Bavi in multiple applications as quickly as desired. It really sounded like the data published Friday has put Peregrine in the drivers seat to dictate the terms they will accept, within the limitation of course that you can only get mega bucks upfront if you give away US co-promotion rights as well as overseas rights.
Regarding timing, if the EOP2 meeting is set for the period just before the holidays, i.e. Nov. 15-Dec 15, then the Company has to finalize its BP term-sheet negotiations in Sept and give the lawyers first half of Oct to close the deal so that the BP and PPHM can work together for at least 4-6 weeks to prepare their joint EOP2 presentation to the FDA
Mojo-- Thanks for all the great graphs you give us. Any chance you could produce one that shows the KM curves for Avastin in NSCLC overlayed on yesterday's KM curve for Bavi at 3 mg/kg? Hopefully there is data out there showing Avastin survival numbers in Stage III an IV NSCLC patients.
After all, it's the total amount of space between the Bavi KM survival curve and the docetaxel control curve that drives the value of the BP partnership SK can command.
It would be a great visual if we could see not only the space between the Bavi line and the docetaxel line, but also the space between the Bavi OS line and the Avastin OS line. I strongly suspect that SK and his team are driving up the value of their BP deal by comparing Bavi's Kaplan Meir OS lines to Avastin's OS lines.
That one image would predict in a nutshell how much bigger the Bavi blockbuster effect in the marketplace will be as compared with the Avastin blockbuster effect.
Thanks in advance. FF
Given that the key data in Gerber's noon presentation tomorrow has already been announced in the Abstract released this morning, I am still betting, even more than in my post 2 days ago, that Shan's slide show and webcast will be released pre-market tomorrow morning and will be accompanied by an embargoed media story in a major newspaper.
This is a perfect set up for an embargoed story. The key scientific info has been released today but the public needs the guiding hand of a good science reporter at NYT or WSJ to explain it and give it context and meaning. Of course the science writer will be able to refer to Joe Shan's webcast and slides for assistance in telling the story.
I'm betting that the Company's PR team is better than the credit that has been given to them so far.
Absolutely correct. It's the same issue.
This time lag in getting patient status updates is also why the general convention followed by the industry is to use the time when you know that 80% of the patients have died as a reasonable time to cut off and finalize your MOS data even if you haven't heard a recent status update from 20% of the patients and don't know their actual death date.
Once these patients drop out of the trial, it's very common to lose contact with them. The families just don't want to deal with the hospitals anymore, either because the loved one has died or is very near death.
I'm quite sure that when SK said "As of a recent date... " MOS has not been reached, he was just being factual and scientifically correct. There is no way he can say with 100% certainty that "As of today MOS has not been reached" because the last patient update could have been several weeks ago and he just doesn't know who may have died in the last 2 weeks.
Nice to hear SK discuss imaging trial 3 separate times. In the beginning, middle and end of talk he repeated how the imaging data would be available for sure in 2012 and said how each patient acts as his own control group.
This is the kind of emphasis you give when you are confident you are going to have some good imaging data to report. SK already knows how good the data looks for the first 3-6 imaging patients. If it were mediocre data, he wouldn't mention it 3 separate times.
SK sounded much more confident that the BP discussions would result in a deal where the Company is able to keep "co-promotion" rights in the U.S.
In explaining Slide 17 he sounded much more bullish than before that the Company could actually retain something like 50:50 co-development rights in the U.S. and a more traditional 15%-20% royalty for Ex-US sales.
Also, at the end when he explained capital resources and corporate structure, he stated expressly for the first time that the BP deal under discussion could yield significant working capital to fund the various programs.
"As of recently ..." simply means that there is a time delay in contacting patients who have left the trial.
IR explained to me that many of the patients have now left the trial and the Company can only get updates on their health and continuing survival about once a month. The Company doesn't have the right to call the patient's home every day to see if they are still living. So as of today you don't know for sure who may have died yesterday or the day before.
All you can know for sure is that "as of a recent date" when you last got a patient update, the MOS had not yet been reached.
Yes there may be a Sunday article in the LA Times about a local Calif. company. But the big national publications are solicited with so many stories that they have a tendency to only cover breaking news if they are granted an exclusive pursuant to an embargo contract.
The embargo contract assures the science writer that his paper will be the only one covering the story, with access to Company management and scientists, for at least one full day.
Getting the scoop before others know it is what sells papers. By "scoop" I don't mean the actual MOS data. That may have to wait for the plenary session. I mean being the first paper to break the news that anti-PS technology works in the clinic and has given birth to a whole new platform of immunotherapy for both cancer and viral disease.
Of course the science writer will see the MOS data this week (under confidentiality) so that he can know what will be said in the Chicago plenary session. He needs to have this info to be sure his story is credible and real before he puts his reputation on the line.
Horselover-- You may well be right. But even if the most significant clinical data is held back and reserved for the Chicago plenary session, there is still quite a story that could be written Friday morning about anti-PS technology and previously pubished Bavi clinical data. Such an article could be a great warm-act for the Chicago presentation and still give the science writer kudos for scooping the story.
The slide deck that accompanies Shan's audio webcast may have all the images and data graphs that the science writer needs to reference in order to make his story complete and compelling ... and leave the reader full of anticipation for the Chicago presentation.
"In conjunction with" the Sept 7 mid-day presentation, is a very open-ended statement.
I think there is an excellent chance that Shan's pre-recorded webcast will be uploaded before the market opens Friday morning in order to give factual support for a NYT or WSJ article that will come out in the Friday morning paper. Pursuant to an embargo (i.e. strict confidentiality), that article may be in draft form already.
If Bavi really is a break through for cancer therapy, the science writers at the major papers will compete to be the first to break the news.
Doesn't it make more sense that the story should come out Friday morning when it really is breaking news. Saturday's paper is too late. As long as the Company announces in advance that there will be a webcast "in conjunction with" the Chicago presentation, and this nutshell outline of the presentation from Shan is available before the market opens, why not let NYT or WSJ be the ones to break the news.
I love these two statements from Thorpe and Shan regarding their presentation at Dec 5 IBC conference that Bungler discovered for us:
Good post Firechief. I agree with your reasoning about the loan and with your conclusion:
FireChief-- Avid's accounts receivable are deemed to be an asset of the 100% Parent Company. I'm sure Avid's revenues are part of the collateral securing the loan.
An important point is that in the PR, Lytle put (a) before (b) when he said:
"Leveraging (a) the proof-of-concept data in our lead bavituximab indication in 2nd line NSCLC and (b) our growing contract manufacturing business enabled us to secure the loan."
This quote confirms your main point, which is that Oxford did a heck of a lot of due diligence on Bavi's performance.
The most impressive thing about the loan is that they got away with 2 tranches of $15M each. I'll bet the banks pushed plenty hard to do the full $30M upfront and lock in the $2.47 warrant exercise price on $30M-worth of warrants.
Instead, the exercise price on the second batch of warrants is likely to be way over $15 per share a year from now. In fact, when the BP partnership deal closes, even if it has only a $50 million upfront royalty payment (which I believe is low by a multiple of 5), the second tranche of this bank note evaporates, i.e. it won't happen and there won't be any more warrants at any price.
The only way the Company got away with this two-tranche approach was because they had another banking group in the wings offering competing terms. In the end, Oxford folded because they did their PS-targeting research and realized it was better to make a boatload of money on $675,000 of warrants (i.e. 4.5% of $15M) than to push the envelope on an upfront $30M loan and lose the deal.
Nice work PL.
Speaking of the Imaging Trial,
I just discovered that the imaging trial started enrolling patients at least as early as June 28. You can confirm this fact by going to www.clinicaltrials.gov and searching for "PGN650" .
If you search for Bavituximab, the imaging trial won't come up. That's because the fully-human Bavituximab therapy molecule is PGN635, but to do the imaging trial they had to cut off the FC receptor on the tail of the MAB so that it would not cause a therapeutic effect when only a PS imaging effect is desired. The new truncated imaging molecule is called PGN650.
I don't why there was no PR announcing the start of enrollment of this trial.
I posted a week ago my guess that the pps will get a jolt from a confirmation during the Sept CC that the Company will be applying for AA.
Now that we know the CC will be on Monday Sept 10 and we know the interim MOS data will be released at the medical conference on Friday Sept 7, my guess is seeming entirely possible.
Once the public has the hard MOS numbers and supporting data (such as baseline levels for patients across different treatment arms) and is able to digest it for 2 days over the weekend, SK will have credibility Monday when he announces that the data strongly supports an AA application.
IMO they will play the analysts and IBs off of each other just like the BPs to see who gives them the best terms. Analyst coverage almost always comes with an IB engagement.
I expect they are talking with several IBs right now. At the very least they will wait to close an IB relationship until after Credit Suisse has had their turn on Sept 20.
Stoneroad- You are correct. Market Cap is the key to what is happening.
With the MOS results PPHM has already achieved in NSCLC, and soon to be repeated in breast and pancreatic cancers, Wall Street is waking up to the fact that this is a Mid-Cap biotech company (i.e. between $2 billion and $5 billion in market cap) and not a Micro-Cap company (i.e. under $300 million in market cap).
Look at this excellent July 2012 Seeking Alpha article explaining the difference between Micro Cap, Small Cap, Mid Cap and Large Cap companies in the biotech sector:
http://seekingalpha.com/article/720411-mid-cap-biotech-stocks-accumulated-by-the-world-s-largest-money-managers
The article discusses three mid-cap companies in the cancer therapeutics markets—MDVN, ARIA, and SGEN—with market caps today of $3.5B, $3.2B and 2.8B respectively.
None of these companies has the potential market “Volume” (as RRdog put it so well) that PPHM has. Yet the PPHM stock price would need to be roughly $35, $32 and $28 respectively to even just match the market cap of these three Mid-Cap biotech companies.
It’s obvious what is happening here: A number of mega fund managers described in this Seeking Alpha article have woken up to the fact that, if PPHM has indeed doubled the SOC in NSCLC, then AA is very likely and PPHM deserves to jump from Micro Cap status to Mid Cap status without barely touching down in Small Cap land.
Assuming that SK confirms at the Wedbush conference on Aug 15 that "MOS has not been reached in either Bavi arm and still has a ways to go," three events will happen shortly thereafter (i.e during Aug. and Sept.), but it's hard to predict the sequence:
1. A major article will be written by a science reporter, e.g. NY Times or WSJ;
2. The Company will confirm (probably in the Sept CC) that it will be applying to the FDA for Accelerated Approval; and
3. A partnership deal with BP will close.
Of course a half dozen other events are also likely to happen in Aug. and Sept. ($30M Term Loan, Sept release of MOS details at a scientific conference, PRs on other pending trials plus imaging trial update), but the above 3 events will be the major stock drivers.
IMHO
FTM-- Agree this is a key question. In my mind, reporting of control group MOS could be deemed "material" under SEC standards for a double-blinded flagship trial, but not be deemed material for a much smaller, unblinded study.
In other words, front line MOS for the control group could well have been reached by now, but simply is not being reported until the treatment arm is also reported-- as is done with most Phase II clinical data.