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Yes, indeed. This was the second time SK emphasized the goal of retaining U.S. Bavi marketing rights,
and both times the context has been the importance of the liver cancer data as a driver of Asian partnership interest. Here is what he said in the Charles Duncan part of Q&A at last week's CC:
Yes, and if I heard right, at the end of the PC discussion he said he would "lay out plans for the next step in developing the PC program about the same time frame."
That "same time frame" would be the ASCO time frame. Does this comment mean that around ASCO we will see a joint PR made with Celgene announcing a clinical study with Abraxane ?
On the Front Line MOS issue raised in CC yesterday, it's worth looking again at the list of 18 historical front line NSCLC trials that FTM reported on Feb 22nd: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84897119
All 18 of these trials reported an MOS figure for both the control arm and the treatment arm without any controversy or second-guessing.
Clearly there are well accepted conventions for handling this issue.
Did anyone else notice a difference between the Cowan slide-- which says Bavi will be the subject of a "Global License"-- and today's remarks where SK seemed to say (if I heard correctly) that the liver data has the potential to result in an "Ex US" license in Asia where liver cancer is a major problem ?
I guess we'll have to wait for the transcript to clear it up. Anyone else hear "Ex U.S." Bavi partnerships, which implies regional licenses rather than a single global license ?
Maybe they want to send mixed signals to the BPs. One week they act like they are open to a global license and the next week they re-open the Asian, regional license possibility for liver cancer as a carve out from the global deal-- just to keep the main bidder honest.
If a Japanese BP was willing to pay $40 million up front for a license limited to liver cancer in the pacific rim, that sure would help to put a value on what the rest of the Bavi global franchise must be worth.
Thank you FTM for finding these AACR Abstracts.
When the PRs from AACR come out on April 8-10 regarding these pre-clinical studies, the market will probably react with a yawn, but this kind of detailed understanding of how Bavi affects the immune system and why Betabodies will be the next therapeutic generation of drugs after Bavi, will further educate (and hopefully motivate) potential BP partners as to both the depth and the potential of the anti-PS platform.
If I understand correctly, the first abstract you posted is important because it establishes that Bavi does trigger the differentiation of MDSCs into DCs (Dendritic Cells), which in turn demonstrates that the Bavi MOA is working at the top of the immuno-therapeutic chain of events. Is this correct?
By contrast, competing immunotherapies have their effect much further down the chain. Correct?
It is quite possible the Company has clear evidence the coding error was done "intentionally" without knowing it was sabotage. For example, maybe the lady who made the error left a paper trail of what she did. Just because an act was done "intentionally" doesn't mean there was also a conspiracy to sabotage the trial. Maybe the lady was whacko or maybe she wanted to punish her employer for some personal reasons.
Legal proceedings are already under way, and the last thing the Company wants to do is undermine their legal position by making accusations in a PR that cannot be proven. It would just give the other side a counterclaim against the Company for libel and slander.
It's better to let the lawyers make the proper allegations in carefully worded legal documents with supporting evidence. In that context there's no risk of a slander or libel backlash.
IMO, the main point Chris wants us to take home is that the FDA knows, and the BPs we are talking partnership with know, that the Company got screwed and that what happened was not preventable by PPHM management.
I have twice been told by Chris that the FDA is being very cooperative regarding the EOP2 meeting. If the coding error was done intentionally, and that appears to be the case, it's not surprising that the FDA is being so cooperative and understanding.
For anyone looking to understand the importance of HR=0.73 in yesterday's PR, check out this link that explains Hazard Ratios:
http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/What_are_haz_ratios.pdf
In particular, go to the discussion of Figure 2b on page 7 of the pdf where this statement is found:
The answer to your question is called "subgroup analysis." In designing the trial Mgmt was already confident that Bavi works-- so they included PS 2 patients in order to get a reading on just how well it works.
In the pancreatic trial, the randomization skewed against the treatment arm and affected the overall result. In hindsight, perhaps that was too high a cost to pay for this additional level of knowledge on how well Bavi works (or doesn't work) in extremely sick death-row PC patients.
In the 2nd line NSCLC trial, the randomization seems to have worked quite well. 75.6% of the patients were PS 0 or 1. That gives them a nice sub-group of 30 patients to see how well Bavi works in these healthier patients.
This is why the Company emphasized in the opening paragraph of today's PR that "Peregrine plans to report additional data from the trial, including updated subgroup analysis and safety data, at an upcoming scientific meeting.
The subgroup data reported at AACR in early April or t ASCO in late May should be very interesting.
FTM-- Thanks for getting out this summary chart so quickly-- it's the picture that is worth ten thousand words. Today the BPs with whom we are talking partnership are looking at the data in this chart, not at the pps.
Could you please help me confirm an important point that appears to make Bavi results today even stronger. In you post #110144 your chart reports that in the Bavi 3mg arm 24.4% of the patients were ECOG PS 2. Where did you get that number? Was it based on all 40 patients as reported back in Sept.? Is it still a valid number today?
ECOG PS 2 patients are MUCH sicker than the PS 0 and 1 patients.
Everyone should review FTM's chart in post 110144 and notice that the 3 other trials reporting treatment arm MOS greater than 10 months (i.e. Herbst in 2010, Pallis in 2010 and Ramlau in 2012) had PS 2 populations of only 1%, 11.9% and 4.6% respectively.
BPs will surely notice that Bavi achieved MOS of 11.7 months in a patient population having twice as many very sick PS 2 patients.
Geo-- Cotara took unusually long because the Company proposed a trial design with no real control group other than historical data from other trials. The Phase III Cotara trial is randomized only in the sense that it compares two different doses of Cotara. This is extremely unusual and it took an unusually long time for the FDA to get their arms around Dr. Garnick's reasoning for this novel approach.
The text book time lines for EOP2 meetings are very likely to apply in the case of Bavi Phase III 2nd line NSCLC, where the Company is simply repeating (with a few more patients) the trial design of Bavi Phase IIb 2nd line NSCLC.
Plus, I heard from CK that "the FDA is being very cooperative." IMHO, this cooperation could translate into a Phase III trial design decision sooner than 60-90 days, but that's just my personal guess.
Co3aii-- You are correct. The big thing that matters to the FDA in approving a Ph III application is the safety of the Ph I and II data. Yes, the FDA would like to see some degree of efficacy, but the efficacy decision basically belongs to the trial sponsor, i.e. PPHM and their BP partner.
If the trial sponsor believes the Phase II efficacy data is good enough to support a decision to throw mega bucks at a Phase III, then the FDA will say "be my guest, go right ahead," as long as the safety data is rock solid.
When we see the big PR (hopefully this week) on the re-constructed 3mg MOS data, the issue will be whether the 2nd line Bavi data, when combined with the pending front line data (that is open label), is good enough to attract a BP partner on very rich $$ terms, average $$ terms, or poor $$ terms.
The timing is working out quite nicely. The FDA approved Ph III trial design will come out of the EOP2 meeting 60-90 days after the application is made, which will happen within days of the PR being released. This means mid-May.
The front line NSCLC data is supposed to "event" in Q2 and will probably be released in some top line form for ASCO on May 15 even if a final MOS number has not been reached by that date.
It is the combo of (1) the 40 2nd line patients who got the 3mg Bavi dose with Docitaxel, plus (2) the 43 front line patients who got Bavi plus Paclitaxel/Carboplatin, plus (3) a look at Pancreatic subset analysis, plus (4) the earlier breast Bavi breast cancer results, that will collectively determine whether we get a very reach BP deal or an ordinary BP deal.
Going into a Phase III lung trial is not in question. Only the terms of the BP partnership are in question.
Purpledawgs-- Thanks for your clarification. I get it now.
This understanding leaves me more hopeful that when Chris Keenan told the WSJ we will see the 2nd line update "shortly", he means next week or at least this month.
Correct. Good point.
Your point underscores again why it is so important to give the Company time to finalize MOS numbers for both arms of the trial that won't change again and can be used for FDA purposes, BP partnership purposes and ASCO purposes.
Think how horrible it would be for the Company's credibility if they had to modify the MOS again for either arm after the pending PR is released
Satisfying the curiosity and impatience of retail investors is, quite correctly, the last thing on Mgmt's mind at this time.
CJ-- Thanks for posting this link to Roth report, which was published on Jan 14 following the Jan 7 PR and following the author's meeting with Mgmt about the Jan 7 PR.
I note that Mgmt. told the author, i.e. Dr. Joe Pantginis, the same thing in early Jan. that I heard and posted on Jan 31 regarding timing of the big PR update on the 2nd line investigation. Here is Dr. Pantginis' statement on Jan 14:
Geo-- My personal guess is that we will see the PR by middle of next week, but that is just a WAG.
As I noted before in post 111350:
Thanks FTM-- That's the story in a nutshell.
Abraxane had 60% who were relatively healthy with PS of 0, and only 40% who were sicker.
Bavi had only 28% who were relatively healthy with PS of 0, and 72% who were sicker or much sicker.
FTM- Thanks for that important clarification. I misunderstood the metastatic point, but I'm confident I understood correctly the ECOG difference between Abraxane and Folfirinox (ECOG 0 and 1 only) and Bavi (ECOG 0, 1 and 2).
Rocking Jack- Your post sounds like my discussion yesterday with Jay Carlson. Some of the PC patients were so sick they died before Bavi’s immune stimulatory effects could develop. That’s why the subset analysis is likely to be more encouraging.
Jay pointed out that the other immuno-therapeutic MAbs like PD-1 and Ipilimumab also require multiple doses over extended time before the immuno-therapeutic benefits show up. Apparently, Ipilimumab was almost abandoned until they realized it needed to be given to healthier patients over a longer period of time.
Also note that the ECOG status of patients in the Fulfironox and Abraxane trials included only 0 and 1 patients, whereas the Bavi PC patients had ECOG status of 0, 1 and 2. If you look up the criteria for ECOG 2, you will see it means being MUCH sicker than ECOG 1.
Also, the Bavi trial included patients with metastatic PC.
The Company views the Phase II pancreatic trial as a signal seeking trial. My interpretation of what I heard (i.e. connecting dots) is that the data revealed a strong signal, especially in subsets that stayed alive long enough to receive multiple doses.
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IMHO, and not based on anything I heard, I speculate that the subset analysis will be for only those patients with ECOG status 0 and 1. This would make for a good comparison with Abraxane and Fulfironox. The sample size would be small, but it could make for a juicy tidbit at ASCO.
Bmkj-- Good post. I agree with your points. I have a comment on your 3rd par. where you say:
“I believe the street is still betting the Ph II 2nd-line NSCLC trial will have to be redone.”
The street is making the wrong bet on that one. The primary question for the FDA when a company elects to undertake a large Ph III trial is safety, not efficacy. The trial sponsors (i.e. PPHM plus BP partner) are the ones who review the efficacy data and determine that the cost of a larger Ph III trial is justified. The FDA just wants to know that no safety issues arose with the Ph I and Ph II patients. CSM’s coding error / mix up of control arm patients with the 1 mg patients does indeed affect the quality of the efficacy data, but has no effect whatsoever on the quality of the safety data--- safety data from all 120 patients in the 2nd line trial will be reviewed by the FDA and given full weight. This is why the Company can say with confidence that the “Data Supports Phase III.”
So the real question is not whether there will be a Ph III trial, but how many patients will be required in that trial (e.g. 300 – 400 patients) and whether the FDA will accept an “interim look” at some smaller subset of those patients (e.g. 100 – 150 patients) as a basis for cutting short the trial and granting immediate approval 1/3 of the way through the trial.
As I said in post 110083, I believe, based on conversations I have had, that such an “interim look” will be allowed as part of the Phase III trial design if the final MOS number for the 3mg Bavi arm released next week comes anywhere close to the 13.1 months announced in Sept.
Regarding a BP Bavi partnership, the Company could negotiate respectable Bavi partnership terms after the MOS numbers come out next week, but the Company’s negotiating leverage will go up if the pancreatic and front-line dat confirms strong Bavi activity and will go up even more if MOS data from all 3 Phase II trials cause the FDA to put a low figure on the number of “interim look” patients needed to cut the trial short.
By end of next week, i.e. Feb. 15, the FDA should receive the Company’s final EOP2 meeting submission containing the final 2nd line MOS numbers that investors also get to see approximately the same time. The FDA will then have up to 30 days to schedule the EOP2 meeting and another 30 days to hold that meeting, and then maybe another 30 days for back-and-forth with the Company to finalize the Ph III trial design, for a total of 60-90 days.
IMO, 60-90 days from now, i.e. by mid-May, we should have:
1. Interim or final results from pancreatic and front line NSCLC trials. Both these trials are open-label, so BPs and FDA will be able to see much more data than the top-line data we see.
2. Based on (1) MOS data from the 3mg arm of 2nd line trial, (2) pancreatic MOS data and (3) front-line MOS data, by mid-May the FDA will finalize a Phase III trial design for 2nd line NSCLC that includes an “interim look.”
3. Based on the "interim look" in the final Ph III trial design, supplemented by the BPs own view of results from open-label pancreatic and front line NSCLC trials, by mid-May Bavi BP partnership negotiations will have closed or will be at an advanced stage.
4. By mid-May at least one of the regional Cotara partnerships should have closed.
5. On May 15, ASCO abstracts will be released for multiple Bavi and Cotara trials.
So the Big Question is: Do you try to trade the stock over the next 90 days as these inflection points happen, or do you sit tight until May when the near-term potential of this locomotive will be fully apparent.
In post 110072 on Jan 31, I reported that the Company believes that Feb 15 is "a good projection" of when investors would see a PR update on results of the 2nd line investigation.
I understand Feb 15 is still a good projection for that event.
In the PR on Jan 7 Jeff Masten said: "We believe we have accomplished our goals in obtaining a more thorough understanding of the trial and we are very pleased with the outcome."
I understand that this continues to be a correct statement, i.e., as of today, Feb 7th, the Company continues to be "very pleased with the outcome."
IMO, they did not update the Corporate Fact Sheet today because they just randomly felt that today would be a good day to give us retail shareholders a bit more information.
Rather, they updated today because the big 2nd-line PR will come next week, another 100 million shares will trade over the course of 3 days next week, and they want all those new investors and new funds to see the current stat of play at PPHM, especially:
1. The "2nd-line data supports Phase III", i.e., the investigation resulted in high-quality data so FDA approval of Phase III is very likely;
2. MOS for front-line NSCLC won't event until Q2, so the improvement of Bavi arm over the historical SOC mean will be in the 40-60% range. This blows away Avastin's results in the same indication.
3. Cotara partnership is starting to get real.
nh-- It would not be an "Inflection Point" if PPHM were merely referring to itself as being a candidate for a Cotara partnership. Everyone has known that fact for a long time.
The new word has to be some sort of comment on what has changed since the last Fact Sheet. If nothing had changed or evolved, they would have just repeated the old phrase, i.e. "Partnership Discussions."
For me the key is that they use the singular rather than the plural. They refer to a "Candidate" singular, which means to me that the former "discussions" have evolved to point where the focus is now on one "Candidate."
Two big developments in the new Corporate Fact Sheet have not yet been noted:
1. For 2nd-line NSCLC, it used to say "Ongoing Internal Review." It now says boldly and clearly: "PRELIMINARY DATA SUPPORTS PHASE III." That is a huge change. Clearly the Company has been speaking with the FDA and already has assurances this drug is going into Phase III for NSCLC under one trial design or another.
2. Regarding Cotara partnership, the old Fact Sheet indicated "Partnership Discussions" were taking place. The new Fact Sheet says "Partnership Candidate." That is a big difference. It appears that at least one BP has moved from being in "discussions" to being a "Candidate."
The statement that the 2nd-line NSCLC program is moving into Phase III is a long-awaited confirmation that the massive vetting and re-validation of the Phase IIb trial results has resulted in quality data that the FDA can rely on. This removes the huge cloud that has been hovering over the 2nd-line lung trial. No wonder the stock is up today.
WH-- Thank you for your beliefs, which inspired me to make my own list.
IMO, and based on conversations I have had, I believe:
1. The FDA is very sympathetic to PPHM’s situation and will schedule the EOP2 meeting within 30-60 days of receiving the reconstructed NSCLC data, which they will receive about the same time we see it in the pending PR.
2. The FDA will approve Bavi to go forward with a large Phase III trial that includes an interim look at some smaller subset of patients. AA may not be entirely off the table, but at least PPHM will get the chance to cut the trial short if results from first 100 or 150 patients are outstanding (like the Phase III Cotara protocol).
3. As SK said in the Q&A at end of the last CC, interested BP partners will make their move to finalize terms of a Bavi license after the FDA finalizes terms of the Phase III protocol. IMO, the FDA discussions will move quickly (because FDA is sympathetic) and could easily conclude by mid April, with a BP partnership concluded around mid-May.
4. ASCO will be a big event for PPHM this year, with presentations of 2nd-line NSCLC, front-line NSCLC, pancreatic and IST data.
5. One or more Cotara regional licenses will indeed close before summer.
All IMHO.
I understand that scrubbing and verification of the data, including updates on censored patients, has been / still is continuing.
I spoke with Chris Keenan today. I pointed out that the Corporate Fact Sheet on the website indicates the Internal Review of 2nd-line NSCLC data will be completed by middle of the current calendar quarter, i.e. Feb 15, which is two weeks from tomorrow. I asked if this time line was still a good projection of when the PR would be released with final data from the 2nd-line lung trial … and he said “YES.”
He noted, however, that the pending PR may include top-line data only and that the PR may say that some of the data is being reserved for presentation at ASCO.
I have heard that the investigation resulted in a very clear paper trial as to which control patients received 1mg and which patients in the 1mg arm received SOC. If this is true, it would only be necessary to obtain PK data on a small sample of the patients to triple check the accuracy of this paper trail.
AF tries to insinuate that the 3mg arm was also corrupted. This is a flagrant lie. The investigation uncovered way to much clarity on what actually happened for the Company to be able to say the 3mg Arm was not affected unless this was in fact the case.
Actually, the last word we had from SK regarding the 2nd line investigation results was this quote from near the end of the Q&A in the CC on 12.10.12:
J&J's new tuberculosis drug, Sirturo, is granted Accelerated Approval today based on a 35% improvement in efficacy compared to the control group in two Phase 2 studies totaling 440 patients.
And this AA approval was granted notwithstanding a significantly higher risk of death in the treatment group.
How would the FDA view a drug that had a 100% improvement in MOS with no increase in safety risks?
As the Company says on the website in their hiring announcement for a Sr. Medical Writer, they are preparing
"... to revolutionize patient therapies for brain, lung and pancreatic cancer" and anticipate a "rapid approval process with the FDA."
I see the $75M ATM filing today as another confirmation the Company is thinking big based on having big clinical data to announce during Jan and Feb for all three Phase II programs, i.e.: 2nd line lung, 1st line lung and pancreatic.
If the quote above from Medical Writer announcement is even half true, AA or Breakthrough status with the FDA is very real and the Company will be able to sell 5 million ATM shares for $40 million ($8/share) by end of Feb.
Alternatively, the Company may sell 10 million shares to a BP for $10 per share as part of the licensing / partnership transaction. That's why the old $150 million shelf is now too low to address the transactional opportunities the Company now has.
Very interesting that the PR today says:
Upcoming clinical milestones ... include ... final results from our second-line non-small cell lung cancer study.
There are no qualifiers on this statement like "may include." Yes, when they talked about a final data set that "could be used to support advancing the program into a pivotal trial," they qualified this statement with "The goal of this review is" and "we believe."
But when the statement regards simply whether "final results" from the 2nd Line study will be published, there was no qualification at all. Mgmt states outright that: THIS WILL BE AN UPCOMING MILESTONE.
Sounds to me like Mgmt. is ready and eager to get the "final results" published regardless of how the FDA views the data. Of course it would be foolish to jump the gun on how the reconstructed data will be viewed by the FDA. But simple publication of the "final results" is indeed certain.
Now you tell me Mr. Fuerstein and DD: Would they be so eager and definitive about publishing the final results if those results were bad ???
Serene-- Thanks for sharing this remark from someone with so much laboratory and hospital experience:
I have a different favorite statement from today's PR:
"Having established a clear clinical path forward for this novel and targeted delivered drug candidate, we can now escalate our business development activities to secure a partnership, recognizing the great interest by companies in drug candidates within the orphan and rare disease space," said Steven King.
It's nice to know that BPs are showing "great interest" in this kind of orphan drug profile. Now that the FDA has given the green light to complete enrollment "within a two-year time frame," it will be easy to structure a partnership with different amounts for the upfront royalty payments depending on how quickly enrollment completes.
The pre-clinical research poster related to the Company's Oct 31, 2012 PR doesn't just "imply" that Bavi increases M1 polarization, it actually states this as a fact. See notes under the Bavi MOA image at the bottom left of this poster:
http://www.peregrineinc.com/images/stories/pdfs/sitc_2012.pdf
Another interesting aspect of the left image in the lower left corner of this poster is that it shows the PD-1 and CTLA-4 markers (which got so much attention and major press coverage at ASCCO this year) as being essentially "down stream" MOAs that stimulate the T-cells as apposed to Bavi's more "upstream" MOA the affects the core of the tumor's immuno-therapeutic stimulatory environment.
Nice post, Nuke. I agree.
They never announced that the EOP2 date had been set, but they did announce clearly at the CC in early Sept that they expected to compete the EOP2 by end of 2012. So they may well have written the FDA to request the EOP2 meeting before the CSM screw up was discovered. Since the meeting has to be scheduled by the FDA within 60 days of the date of request, the original EOP2 meeting may have been scheduled to take place as early as this month. Hopefully it can be rescheduled to occur at least in Dec if the FDA finds the data to be admissible.
I like your point that if data is good enough for Joe Shan to present at the Dec 5 conference, it should hopefully be good enough for the FDA to review in a Nov or Dec EOP2 meeting.
IMO, Scenario #1, the minimum level of clarity the FDA needs to give, is that they will treat-- or not treat-- the reconstructed data the same as if the CSM error had never happened for EOP2 planning purposes. Under this minimum clarification scenario, if the FDA accepts the reconstructed data the same as normal data, the EOP2 meeting might be scheduled for January, i.e. within 60 days of the decision to accept the data as normal and untainted. The basic clarification here would be that PPHM does NOT need to repeat Phase IIb.
Scenario #2 is probably wishful thinking, but it would be nice if the FDA went on to recognize that the Company originally requested the EOP2 meeting to occur before the end of 2012, and it was not PPHM’s fault that the FDA’s licensee, i.e. CSM, screwed up. Under this Scenario the FDA would actually hold the EOP2 meeting as part of all the other data review they are doing right now and tell PPHM, and its pending BP partner, how many patients will be required in Phase III and whether there will be Accelerated Approval.
If Bavi really is a break through in immunotherapy and really is showing amazing MOS in both 2nd line NSCLC, front line NSCLC and pancreatic cancer, there may be a lot of pressure on the FDA to do Scenario #2 and get this show moving again.
CP-- You are correct that, in order to prevail on their class action claims, plaintiffs must prove more than ordinary negligence. The case law on securities fraud cases talks about the need to prove "scienter" , which is a state of mind where the defendant either had actual knowledge of the CSM error or "reckless disregard" for the possibility of that error.
My point is that "reckless disregard", also known as "gross negligence," will be impossible to prove with respect to the CSM error, but would be feasible for plaintiffs to prove (or at least argue credibly and force a settlement) if the FDA tells the Company it has to repeat Phase IIb just weeks after the reconstructed data is announced.
Especially when the FDA is already in close dialogue with the Company about what happened and how it happened, plaintiffs would argue that the Company "knew or should have known" that an FDA rejection of the reconstructed data was imminent.
IMO, Management would be crazy to expose itself to the claims that will follow another roller coaster stock price ride (i.e. up on the news of strong reconstructed data and down on the news the FDA will require Phase IIb to be repeated), when the whole problem can be avoided by just waiting 2-3 extra weeks to get the FDA sign off. The last thing we need now is a dramatic upward movement in the pps followed by another dramatic downdraft. That kind of price turbulence invites lawsuits.
You make an excellent point in one of your other posts that it is easy for PPHM to control the timing of when the reconstructed data becomes "material", i.e. when the PR is issued, by simply conducting yet a 3rd or 4th layer of independent review of the data. So if another 2-3 weeks is needed to wrap things up with the FDA and issue a complete PR that covers ALL material issues, IMO they will take it.
EBS-- You and Geocappy raise a fair point. IMO, I think this one falls in the area of a judgment call that could go either way. Quite possibly the disclaimers regarding what FDA might do with the data could be viewed as more "material" (i.e. more relevant to a buyer's decision to buy or sell) then the data itself.
When the disclaimers start to be more important than the disclosure itself, and it only takes another 2-3 weeks to remove the FDA uncertainty, IMO it's a close call. Damned if you do and damned if you don't. This is why I think they may have made a CYA call to the SEC for their input on the question.
Also, as a practical matter, imagine how that PR would have to read:
"We have reconstructed the data and have now determined that Bavi's MOS in 2nd line NSCLC was 14 months with a good safety profile, but all investors are advised that the FDA may reject this data and require nonetheless that we repeat our Phase IIb trial."
When the disclaimer is more important than the disclosure, you can't just bury the disclaimer in the footnotes.