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Important NYT article on how patent battles are settled between brand-name BPs and generic competitors who challenge the BPs patent.
http://www.nytimes.com/2012/07/27/health/policy/drug-makers-deals-with-generic-rivals-may-face-justices-review.html?hp
Two take-aways:
1. You need to be in bed with a large, deep-pocket BP who can foot the cost of years of patent litigation because cash payments to pay off the generic company and make it go away will no longer be possible a few years from now.
2. All the money PPHM has invested year after year for 20 years to build the depth and breadth of its anti-PS patent portfolio will pay off in spades. Since BP now has to win the patent battle with the generic challenger, not just pay a large settlement sum to make the problem go away, BPs will pay up big time for a strong patent portfolio.
BPs don't want to pay the price that Mgmt. is now prepared to insist on. If Sept arrives and the MOS has still not been reached in 2nd line, and front line MOS is also looking good and pancreatic results are confirming lung results, I'm guessing the outcome of all these cross currents will be a postponement of the EOP2 meeting to Q1 of 2013.
It's going to take some time for BPs to realize that their first and second offer, even their third offer, is just not good enough to cut a deal. The longer the bidding war lasts and the more that the data from all 7 pending trials reinforces the same clinical truth, the more BP will be willing to pay.
SK said it takes at least 60 days to schedule an EOP2 meeting. Nothing happens after Dec 15 so Oct 1st is the last date to close a BP partnership if the BP is going to participate in an EOP2 filing made by Oct 15. But there is a good chance that 2nd line MOS won't even be finalized by Sept 30 and strong, confirming data from the other 6 trials may only be starting in September.
I'm betting/hoping SK tells us at the Sept CC that the EOP2 meeting has been pushed back. Just like the Mom who announces to the children that bedtime is 9:00 pm, she says that to get the process started, not because that's the real deadline.
The AA-approval advantage from going to the FDA with a BP at your side is huge. The partnership-price advantage for the Company from letting the data in all 7 trials mature to the point where AA is assured is also huge. Come October, SK's best negotiation tactic may be to go silent for a few weeks and see which BP steps up to the plate and meets the Company's terms.
IMO, EOP2 before year end is a very artificial deadline. Let's watch and see.
KT-- I think you just spelled out why fully humanized Bavi- PGN650-- will be so good as a foundation for the Company's new Diagnostic Imaging Division.
While I understand SK's remark in the CC that he may have to accept a co-development deal in the US in order to close a BP therapeutics partnership, I certainly hope that they are able to keep the new Diagnostics Division OFF the table and out of this transaction.
I haven't crunched the numbers, but I'll bet the Bavi Diagnostics Division two years from now is worth far more than Cotara-- assuming Cotara gets commercialized.
Yes, AA and a $25M Term Loan will be important leverage in getting a good deal from BP, but I think Thorpe's presentation at the NY Academy of Science will be just as powerful a factor.
After showing safety and efficacy, the next most important thing is being able to explain your MOA, i.e. how the efficacy is being achieved.
It's clear from the NYAS presentation that Thorpe has completely nailed the MOA both for Bavi's ADCC vascular destruction mechanism and for Bavi's blockage of the PS immuno-suppressive mechanism.
Thorpe's ability to explain in-depth Bavi's MOA will greatly help in moving Bavi through the FDA for all indications... and in turn give the Company more leverage with BP.
FTM, if we can get through October without a front line Bavi MOS announcement, we should be in great shape. That would mean Bavi MOS is at least 13.5 months. I agree this would be a great result compared to Avastin's 12.3 MOS, especially given that Bavi has a better safety profile than Avastin.
Given that Bavi will be on the market and available to all oncologists based on its 2nd line NSCLC data, all we need to show is that we are safer and somewhat more effective than Avastin to become the SOC in front line NSCLC as well.
This is another reason why we may not see a BP deal close until October. If the Bavi MOS data in front line is looking good and still has a ways go by mid October, this will certainly be factored into the price the Company can command in its BP partnering negotiations.
FTM-- Thanks for your help today. I have been so dazzled by 2nd line data that I lost track of the front line story.
It seems to me that the July 16 PR, where the Company said it "anticipated" the MOS event in the 4th quarter, was a subtle way of communicating that they expect the Bavi treatment arm to beat the 12.3 month MOS marker that Avastin achieved with C&P in the Sandler trial.
Front line enrollment completed prior to the PR on Sept 8, 2011.
It would be nice to know that the control arm MOS has already evented, but I'm willing to believe that it will come in fairly close to the 9.8 month mean you reported from 12 different C&P trials. Even the highest C&P control arm result in that group of 12 trials was only 10.5 months.
The main thing is that the Company has signaled that Bavi in the front line trial will beat Avastin's 12.3 months in a similar front line trial. That is good news.
FTM-- I forgot one thing. In the front line, control arm data you gave us in post 81830, could you please advise which of those 11 historical trials used carboplatin pus paclitaxel as the control arm drug similar to the control arm in PPHM's front line trial ?
Also, if you know what the product wrapper/insert says for C&P MOS in front line, that would be very interesting to know.
Thank you.
FTM-- Regarding the front line NSCLC trial, the PR on July 16 said:
"There are currently two trials evaluating bavituximab in front-line NSCLC. A randomized Phase II trial evaluating bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in 83 evaluable patients with previously untreated Stage IIIb and Stage IV non-small cell lung cancer. The trial completed enrollment in September of 2011 and median OS from this trial is event-driven and anticipated in the fourth quarter of 2012."
Yes, it would be helpful to know if MOS has already been reached in the control arm. But I can see that the Company might determine control-arm MOS to be "material" for SEC disclosure purposes when the 2nd line data was unblinded in the Company's double-blind flagship trial, but determine that the same control-arm data in a smaller, non-blinded trial would only become "material" when both treatment arm and control arm data were known.
Also, can you please tell us all how our Bavi treatment arm MOS in the 1st line trial stacks up against other historical front line treatment arms assuming Bavi MOS in the front line trial occurs in November, i.e. the middle of the 4th quarter, i.e. the "anticipated" release time in the PR ?
The last historical MOS data I remember you posting for front line NSCLC trials was for control arms in your post 81830.
Thanks so much.
I would like to see more discussion on this Board of these 2 statements from JMP Slide #16:
"-- Focus on ex-US partnering with Peregrine retaining significant role in US development.
-- Goal is bring partner on board prior to initiation of Phase III and preferably prior to EOP2 meeting."
IMO, there is a huge amount of new content here. Here are my comments:
1. "... with Peregrine retaining significant role in U.S. development" suggests to me that the Company has learned from BP negotiations so far that the big bucks will only come from granting a global Bavi license to one BP suitor and then "retaining" in the US something like a 50:50 co-development agreement. By contrast, in Europe and Asia the deal will look more like a traditional license where PPHM gets a 15% royalty and big milestones. Prior to reading this statement, I thought the Company was going to be able to do a regional Bavi license for Europe or the Pacific Rim but make no commitments for the next 12 months regarding US market.
2. I read the 2nd statement in Slide 16 as very bullish. I think this statement was written to and for the BPs with whom the Company is now negotiating. Mgmt is signaling here to BP that they are willing to wait all the way to mid 2013 when the Phase III starts to close a deal if that's what it takes to get full value for the anti-PS platform. The Company is telling BP that, with Dr. Garnick at their side, they are very willing to go through the Phase III [Accelerated Approval ? ] FDA planning process on their own if necessary and then make BP pay double because AA is in fact granted. "Preferably" BP will see the sense of paying full value in August or Sept before the EOP2 meeting, but if not, the Company is willing to file for AA on their own.
I hope others will share their thoughts on the implications of these 2 key statements. I hope this discussion is read by one of the analysts who gets to ask questions during the CC so we can hear SK himself develop and expand on the meaning of these 2 big statements.
drlab-- Could you please provide the link to this article. Thanks. FF
Let's say the first two regional BP deals announced in August or Sept each bring in $50 million in up front license fees. The pps will quickly multiply, analysts will do the math and publish reports on what the Company could be worth if all the other Bavi applications work out ...
and then about 6-12 months after the first two regional licenses have closed and dozens of new Company trials and IST trials are underway and the Company has a $3-$4 billion market cap, that's the time to start negotiating a merger or sale of the entire anti-PS franchise for a multiple of its then current market cap.
I don't think SK put up for so many years with all he criticism that he should have monetized the IP much sooner to suddenly reverse his strategy (now that it's paying off) unless the pps is 30-40 times higher than where it is today.
Thank you FTM. Exactly the point I was trying to make in the last paragraph of my post 81866.
The 2nd line NSCLC trial was unblinded in mid-May.
At that time it was decided that completion of the MOS for the control arm was a "material event" and needed to be announced.
Completion of MOS for either Bavi arm of the same trial will also be a "material event" immediately when it occurs. The fact that scientists cannot yet determine "statistical significance" has nothing to do with the securities law determination that a "material event" has occurred and needs to be announced.
Mojo-- I hope we'll get an answer to this question during the July CC.
In the interim, it is my understanding from PR that SK and others from the Company are on the data monitoring committee.
BTW, do you think that it was the data monitoring committee that decided it was "statistically significant" to release MOS for the control arm in the 2nd line study, or Ziebell and Keenan?
Did the data monitoring committee decide to selectively unblind the control arm data but not the Bavi arm data? Wouldn't that defeat the whole purpose of the blinding?
IMO, two very different standards used for very different purposes are being conflated.
For scientists, "statistical significance" is the key test. For the SEC and the markets, "material event" is the key test, i.e. would the data, if announced, cause a reasonable investor to either buy or sell the stock. The statistical significance test is determined by scientists and independent data monitoring committees. The "material event" test is determined by securities lawyers and PR reps.
For the Avastin trial discussed in MoJo's post 81849, the DNA lawyers and PR people decided there was not a 'material event" when the avastin MOS date was first reached because, when this data was compared to the size of DNA overall, all its other drugs on the market and the hundreds of other Phase III studies it has run, this particular piece of MOS data would not influence investors to buy or sell DNA stock.
By contrast, when Mark Ziebell and Chris Keenan decide whether the the actual MOS date for the two Bavi arms in PPHM's first and only flagship double blind study is material to an investors decision to buy or sell PPHM, they are reviewing a far different landscape.
Clearly Ziebell and Keenan thought it was material to tell us that MOS for the control arm in the 2nd line study was less than 6 months. Do you think they threw out this information just for fun or on a whim? No. They gave us that data point because in a small company like PPHM on the eve of announcing the key MOS data for its most important flagship trial, knowing the MOS for the control arm was clearly material to any investor looking to buy or sell this stock this summer. There is absolutely no doubt in my mind that if Ziebell and Keenan concluded that the control arm MOS data in in the 2nd line NSCLC study was material, they have already concluded that when Bavi MOS is reached in either arm of the same study IT MUST BE REPORTED WITHIN 72 HRS.
FTM-- Thanks once again for all the great analysis.
I note that in your 2nd line NSCLC "Treatment" table, the two outliers both achieved MOS of 10.3 months, but when you look at the control arms for those two outlier studies, MOS for docetaxel alone in the Herbst study was 9.9 months and 7.7 months in the Pallis study.
By comparison to the docetaxel control arm in the Bavi study where MOS was under 6 months, the Bavi treatment arms will be looking much much better when they get to the 10.3 MOS mark.
As you point out repeatedly, and correctly, patient inclusion criteria vary greatly from study to study so the only thing that really counts is Bavi's performance compared to the control arm in the same study.
Separately, it seems clear that Bavi MOS in the 2nd line study, when reached, will be a "material event" in SEC parlance that MUST be announced within 72 hours. It's way too obvious to everyone that the MOS number for Bavi in a controlled double blind study is a number that will cause reasonable investors to buy or sell the stock. This would be true even if the control arm MOS had not already been announced. But it's doubly true when the control arm MOS was under 6 mos. and we are already over the 9 month mark for Bavi. You don't need a calculator to know that is statistically significant !
Thurly-- IMO, your list of near term pps drivers should also include the imaging trial on 12 patients that should complete, including published results, by late July or mid August.
Really good uptake images, with no surrounding uptake in healthy tissue, will also support a favorable FDA decision on AA.
In my mind, the only "IF" is whether all the data comes in consistently. If it does, I am not worried about whether they can close several BP deals.
Will MOS be strong for both of the Bavi arms in the 2nd line NSCLC trial?
Will MOS for Bavi in the front line NSCLC trial be better than the control group?
Will the imaging trial light up only the tumors without lighting up healthy tissue?
The good news from running 8 trials concurrently this summer is that, if efficacy and safety are good in all trials, it will provide overwhelming proof that Bavi works and is a huge new breakthrough platform.
The bad news from running 8 trials concurrently is that, if one or two trials come up with inconsistent data, there will be a question, a hesitation, in BP's mind because it's a new MOA and BP will have grounds to argue for a lower price on partnership since there is still risk.
One of the most re-assuring comments I have heard on this score was during a recent CC when SK said how encouraged the whole team is that so far all the clinical data is tracking very closing with the pre-clinical data. You know that is often not the case when you move from animals to humans. The strong correlation between pre-clinical and clinical data translates to predictability.
JR-- You make a fair point. The basis for continuing optimism is that there is so much overlapping, reinforcing clinical data this time around and so much of it is of such high quality, i.e. double bind or at least randomized.
Also, I am putting a lot of stock in the imaging trials. If the tumors light up in humans any where near as well as they did in the AACR pre-clinical studies, it will be a huge confirmation of Bavi's MOA.
I think the cumulative effect of so much consistent good data in so many different tumor types will deliver the message to BP that Bavi has proven itself and is worth partnering with significant dollars.
Once the data, including the imaging confirmation, reaches the "tipping point"-- and I think that happens be middle or end of this summer-- there are enough BPs out there who want to have the next Avastin that even a college kid could structure a hot deal with a competitive negotiation process among 2-3 different BPs.
Remember, Bavi's unique, two-fold MOA represents an entirely new platform. Compared to "me-too drugs", a paradigm shifting platform like Anti-PS (and the other new immuno-therapies), has to put twice as much proof on the table before it will be taken seriously. But once the imaging data and 3 randomized Ph II trials all produce consistent efficacy results in multiple tumor types, and the safety profile is good, every BP will want a Bavi license because it turbo-charges their own chemo drug or ADC drug.
It's not a question of "can PPHM Management pull off a deal." Rather it's a question of whether all the data from the different trials, including the 12-patient imaging trial, will produce a consistent story.
I give Management huge credit for orchestrating 3 randomized trials, 4 ISTs and an imaging trial so that all the data comes out roughly the same time this summer and fall. That's exactly the kind of proof a small, poorly-funded minor-league biotech has to come up with in order to negotiate their way into the major leagues.
Of course the Plan the Company submits to NASDAQ on Sept 25 requesting an additional 180 days to achieve compliance also has to mention a r/s as the backstop, failsafe option in March 2013.
Yes, authorization of the r/s may be included in the regular annual meeting proxy materials published in late August, but I could also see the Company feeling very bullish in late Aug about the status of pending BP negotiations and deciding to spend the extra $40K it costs to hold a special shareholder meeting in Feb 2013 solely for the purpose of authorizing the r/s ... if need be.
A lot of big deals in all industries get discussed over the summer and then get negotiated in earnest and closed in Sept and Oct. when the full Board is back from vacations.
Geo-- No, I don't have a good guess on the $$ figure for an ADC alliance. But my opinion is that any deal with a major BP, regardless of dollar amount, would give the Company the missing credibility it needs to get over $1.00.
PPHM received a notice from the NASDAQ on March 24 that allows them 180 days, i.e. until Sept 24, to regain compliance with the $1.00 minimum bid price requirement.
However, delisting will not occur on Sept 24 even if the $1.00 price test has not been met because the Company is allowed to then present to NASDAQ its Plan for regaining compliance during a subsequent period that could last up to an additional 180 days depending on the strength of the Plan. The Company would explain, for example, why they are on the cusp of closing a large BP partnership or non-dilutive financing that would validate the technologies and take the price well over $1.00. Copies of pending correspondence and negotiations with BP would be attached to the Plan to verify the Company's near term prospects.
As long as the Company is well under way with its BP licensing / partnership discussions by late September, it would be easy for the Company to get an extension through Feb or March 2013 to close one of the deals that is pending in Sept.
Thus the Company will have enough time to put into play all 5 of its data-driven BP opportunities:
1. MOS from 2nd line NSCLC trial;
2. MOS from 1st line NSCLC trial;
3. Antibody-drug-conjugate (ADC) deal driven by imaging data available in late July;
4. Cotara partnership based on an FDA approved Phase III protocol; and
5. Data from the pancreatic trial and the 4 IST trials.
I failed to note that your time line is off by one month. The 04.03 PR says: "This program is highlighted with data presented yesterday at the Annual Meeting of the American Association for Cancer Research (AACR) and with the recent filing of an Investigational New Drug application with the United States Food and Drug Administration (FDA)."
So the correct time line is 04.03 + 30 + 30-60 + 15 = mid July.
Agreed. I am assuming an aggressive time table. But I also believe Management is fully aware that they don't have much time left to pull of a major money deal. They know they are in the count down for either success or another r/s. Why wouldn't they be aggressive.
It's clear that PPHM knew many months ago that ADC is the sexy rage in every small or big Pharma company. They didn't have to wait to read about it in the May 31 NYT article like us. That's why both the 04.03 PR and the PPHM imaging website page ( http://www.peregrineinc.com/technology/ps-imaging.html ) list ADC therapy as the first purpose and application that will result from a successful imaging trial.
Again-- I don't think it would be an "imaging deal", but there might very well be an ADC therapy deal if the imaging results are as good in humans as they have been in animals. Good, highly specific images prove that PGN650 is a superior candidate for ADC, not to mention that it works with multiple tumor types.
So far all the pre-clinical data in animals has held up in clinical studies. Let's hope for similar "exceedingly clear" images in humans in July.
Because enrollment has not started yet. According to IR, FDA approval of the 12-patient protocol happened automatically 30 days after the IND application was filed, i.e. approximately 05.03. Then I am told it takes one or two months to get through the Clinical Review Board at the research hospital where the trial will be conducted ... and then enrollment begins and the trial is posted on ClinicalTrials.gov.
I am expecting that the PR announcing the start of enrollment will issue before end of this month, maybe early July, and initial results should be available by mid or late July. From the PR: "The imaging clinical program brings an opportunity for rapid results since each patient can be independently evaluated and conclusions drawn in just a few weeks time ..."
Others should call IR and ask whether the 12-patient clinical imaging trial will start "soon" and post what they hear.
and my point is that your prospects for seeing a money deal close in August will double if the PGN650 imaging trial results-- available in late July-- are good. If the imaging results in July are good, a BP license of PGN650 for ADC applications is just as likely this summer, maybe more likely, than a Pacific rim regional license of Bavi for NSCLC applications.
From the 04.03 PR: "In preclinical studies, 124I-PGN650 accumulates in tumor vasculature and provides exceedingly clear in vivo tumor images." These "exceedingly clear" images are evidence of PGN650's high specificity for PS, which is what also makes it such a good ADC candidate.
See PPHM's website for more discussion of the ADC potential of PGN650 resulting from the upcoming July clinical imaging trials:
http://www.peregrineinc.com/technology/ps-imaging.html
See also the link found on this page to important imaging data presented at AACR this year.
Here's the May 31, 2012 NYT statement on ADCs that shows why SK mentions ADC as the first application of Bavi's pending PGN650 imaging trials:
"Numerous other companies, from pharmaceutical giants to tiny start-ups, are pursuing the treatments, which are known variously as antibody-drug conjugates [ADCs], armed antibodies or empowered antibodies. “I don’t think there is a major pharma or a midsized pharma with interest in cancer that doesn’t have a program or isn’t scrambling to put one together,” said Stephen Evans-Freke, a managing general partner at Celtic Therapeutics, an investment firm that recently committed $50 million to create a new company, ADC Therapeutics, to develop antibody-drug conjugates."
http://www.nytimes.com/2012/06/01/business/a-new-class-of-cancer-drugs-may-be-less-toxic.html?pagewanted=all
From the o4.03 PR: "Data presented yesterday(1) at AACR demonstrated that a near infrared-labeled PS-targeting imaging agent (NIR-PGN650) was able to specifically identify and target multiple solid tumors." Does anyone else see that Mr. Evans-Freke's $50 million ADC investment fund might be interested in such an ADC candidate?
If Bavi proves out in humans to have the same high specificity it showed in pre-clinical studies, the company will start by selling Bavi for therapeutic ADC partnerships, not diagnostic imaging partnerships. I agree the imaging diagnostic business is still a ways down the road.
But you miss the point of what SK was clearly saying in the 04.03 PR. Assuming the Bavi images in July show that Bavi labeled with NIR (near infrared) lights up the tumors beautifully without lighting up healthy tissue, it will be an ideal candidate for partnerships with all the BPs now developing ADC therapy products. See 2nd paragraph of the 04.03 PR. The first of 3 application that SK mentions for PGN650 is ADC !
During ASCO there were several articles published saying that every major player in the oncology market now has, or wants to have, ADC candidates under development. After Roche released at ASCO such impressive results for its ADC molecule T-DM1 in HER2 breast cancer, BP's quest is in full force to find high specificity antibodies to use in new ADC conjugates.
So what what would be BP's interest in a molecule like Bavi that was not only highly specific to tumor tissue, but also shows that it works equally well on multiple cancer types ? Roche got all that attention for its new ADC drug that only works with HER2+ breast cancer.
All I am trying to point out is that we don't have to wait until end of year to see the Front Line MOS data to get the second major test of Bavi's efficacy and potential. The PGN650 imaging data that comes out in July is going to be a huge confirmation-- or not-- of Bavi's potential. From my conversations with IR, it's clear the Company is very excited about what the results of these imaging trials, which will be known "within just a few weeks time."
As a send off to the weekend, I remind everyone that the new clinical imaging program with fully human bavi, i.e. PGN650, is likely to begin enrollment in late June. The PR was 04/03/12, the FDA approval was 30 days later, and I was told by IR it would take a month or two after that to start enrollment.
In light of all the attention antibody-drug-conjugates (ADC) received at ASCO (see the big NYT article), it's important to remember this sentence from the 04/03/12 PR: "Results from this study may open the door for multiple applications including antibody drug conjugates (ADC)."
Due to the extremely toxic payload ADC antibodies carry, ADC works best with high specificity antibodies (like Herceptin for HER2+) that go mostly to their target and don't attach to other cells.
We know from the AACR imaging abstracts that fully-human bavi appears to be such a high-specificity antibody. Results from the human imaging studies will be known just a few weeks after enrollment begins (see 4th par. of the PR). It could well be that by mid or late July the Company has a huge new confirmation of how Bavi works and that Bavi is indeed an ideal candidate for ADC joint ventures and partnerships with BP.
To see how the July imaging studies could confirm Bavi's MOA and lead to a whole new set of ADC negotiations with BP, read these two statements from the PR back to back:
"Results from this study may open the door for multiple applications including antibody drug conjugates (ADC), ... ."
"At any point during the trial, successful images from the 12 anticipated patients in the study coud provide a compelling rationale to expand the PS-targeting imaging platform ino several promising new areas."
Personally, I believe that FDA will have to consider AA if we get both 50% improvement in the MOS and compelling clinical images from fully-human bavi. Both sets of data will be known by end of July.
The clock is ticking. Bon Weekend. :)
Thanks FTM. It looks like we'll just have to wait and see whether MOS for the front line control arm can be reported by the CC date in mid July. Based on a mean of 9.8 months for 12 other C&P control arms, it will be close.
I do know from people I speak with that what really counts for clinicians (and presumably the FDA as well) is the ratio of the new-drug arm to the control arm in a randomized trial. The absolute ORR, PFS and MOS numbers are interesting but not really that meaningful since patient populations vary so much.
Thanks FTM. Here's link to another article on BMS' two anti-PD therapies:
http://www.oncbiz.com/blog/2012/06/the-belle-of-the-ball-pd-1-as-a-hot-new-target/
Question regarding Front Line Trial??? In your post 80725 you added the 2012 Socinski trial which had an MOS of 13 months. What was the MOS for the C&P control arm in that study? What was the mean of the MOS in all the C&P control arms?
I ask because I see we are coming up Juy 8, which will be the 10 month marker since Front Line enrollment was completed. It seems to me the Company should know the MOS number for the C&P control arm by the time of the next Conf. Call.
It would be great to hear in the CC that MOS for the control arm in front line trial has occurred so we can know with each passing week that the Bavi MOS data in the front line trial is confirming the excellent 2nd line trial data.
While the FDA and BP partners should be willing to make an AA decision and a strategic partnership decision based only on the double blind 2nd line data, I suspect they will also want to see confirmation that Bavi MOS data in the front line trial is consistent, i.e. in both trials Bavi MOS was significantly better than control arm MOS.
Thanks again for all you do to make the dialogue on this board meaningful.
Oops. Memorial Day is May 28th. That is the week before ASCO !!!
FTM- I agree with your Independence Day and Labor Day forecasts.
Just for fun, I'll wager with you that we see the 2nd line ORR and PFS numbers the week before ASCO, together, maybe, with MOS for the docetaxel-only control arm.
Yes, the MOS from the control arm could indeed be announced in late May before ASCO and could indeed be an important selling point, especially since it can be compared with the PFS numbers from the 2 Bavi control arms.
If half the control arm patients are dead in late May when the PR comes out, but by comparison on the same date in late May either one or both Bavi arms has just passed the point where half the patients have progressed, this will be a very good sign that Bavi MOS numbers will come in quite strong.
Let's remember that the reason why the trial was not unblinded in March or April is because there were still many stable patients who had not yet progressed during those months. If the average historical median PFS from 10 other trials is 2.7 months for this patient population, it's a very good sign that we are out almost 7 months now and this trial has not been unblinded.
Every week that passes with no PR on the unblinding of the trial makes it that much more likely that the data will be good. The Company's silence speaks volumes. The Company isn't too concerned if most posters on this board don't get it. BP is stepping up their due diligence with each passing week and that's all that matters to management.
Yes, I did ask that exact question. The answer ranges from trial to trial. Sometimes it takes only 2 weeks to organize and verify the data from the time it is unblinded until the time it is presented in a PR.
In other trials the sponsor wants to also fly to various trial centers to speak with nurses to understand adverse events, etc. and the total time from unblinding to PR could stretch out to 4 weeks.
So IF I am right that they want to release their 2nd line data the week before ASCO, the unblinding is probably taking place next week.
My oncologist friend who does clinical trial work has explained how the unblinding process works. As I understand it, there is no room to delay the unblinding once the median PFS point has clearly been passed in all 3 arms. Once there are only 20 stable patients remaining from the 120 total population and everyone else has progressed, they have to unblind the trial because there is no valid reason to keep it blinded--- given that median PFS has necessarily been reached in each of the 3 arms.
However, if the CEO of the trial sponsor is willing to unblind the data earlier, i.e. when there are still 25 or 30 or 40 stable patients, then that is his call because doing so could introduce bias into the reading of the final PFS radio images.
But if 8 months have gone by and the historical PFS range for the docetaxel only control arm (i.e. 2.7 months) has long been passed, and a huge PR opportunity at ASCO is available, why wouldn't SK unblind the data a bit earlier than he has to.
So to get back to your post, yes, logically what you say makes sense from a PR point of view, but my understanding is that SK is ethically and scientifically under an obligation to unblind the data once it is mature, which in this case means only 20 remaining stable paitents.
That's why it's such good news that there has not yet been an unblinding of the data. It means there are still quite a few stable patients. Let's just hope they are all in the two Bavi arms and none are in the control arm.