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"Quote: A priority review voucher is very valuable. Some of companies that are granted them will turn around and sell them for hundreds of millions of dollars."
That is fascinating and very good to know. But it is also disgusting. Just unbelievable that such could be sold. What a joke our country is. Everything is for sale. Including your (figurative) wife to her boss. It is a tradition here.
No... it's probably the whole planet. I am betting on the aliens this time come June 24.
Prins Video: 2 Points of Solid Reassurance regarding efficacy. These do not necessarily translate to reassurance about the business or SP end, but I like having at least one dimension tied down tightly.
1) Prins re-itterates Linda Liau's assessment of the matured, early, open label trial data to strongly indicate outstanding efficacy for the mesenchymals.
2) In Prins' presentation there is a slide that list the three most promising new cancer therapies. They are the T-Cell therapies, the Blockade Inhibitors, and DCVax(-L). I don't remember if the list shows DCVax or DCVax-L, but I think -L. This is reassuring because later Prins talks about improvements that can be made in the Dendritic approaches used so far. Based on these earlier statements he is not saying they are not great, he is just looking for the next direction for improvement. He is a researcher. That is what he does.
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But Ouch! Regarding share price movement today. But the entire XBI is down hard. This is not NWBO specific.
But I feel you Afford. This silence has us all on all fours waiting for the big carrot or the big stick. It is a little uncomfortable waiting. All kinds of horrible things could be in process.... or not. I hate the blind fold. Did you feel those drops of molten wax? That is a good sign, right?
The only thing that really scares me, to be honest, is the radical change to the warrant price. I can come up with explanations where everything will still be ok soon, but it does feel like I am reaching.
So lets work on rationalizing that big warrant price change together. A group effort. How many warrants were outstanding? Ie, what was the real long term loss in financing? If the total dilution is not a large percentage then maybe this is not all that toxic.
The change makes the warrants likely converted sooner rather than later, albeit at 1/3 the gain. Maybe later is not such a big concern. Maybe she knows or strongly suspects that the extra $2 per warrant down the road would be inconsequential... down the road.
"Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients With Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1 (NYM)"
If they find a way to get the costs down, the T-Cell therapies sound wonderful. But the last I looked, they were only being used on blood cancers. The last I looked was maybe 18 months ago, but my vague recollection is that they experienced cytokine storms (out of control immune responses that endanger the patient) when attempting to use these therapies on solid tumor cancers. For that reason, I don't see why they would want to mix such with a blockade inhibitor. I can't see the blockade inhibitor quelling the cytokine storm, but rather, exposing the patient more directly to the storm.
Unless... the Blockade Inhibitor allows them to use less of the T-Cell therapy, resulting in less of a cytokine storm.
New areas of development, so who knows. I should not pretend to know. Even if everything I say here is correct, these things seem well worth trying out for patients that have no other options. Maybe they will hit a magic cocktail. Maybe it will involve a T-Cell therapy. Maybe a Dendritic Cell therapy. Maybe a DCVax.
Regarding Reason for hold: I have been reading these Sentiment, and hope that ultimately it turns out to be the sponsor that initiated the hold, as the first chart states... but
1) That was not the impression I got from related NWBO SEC statements.
2) It is not clear what all the options are for that entry in the tables.
I only see three entry types for all entries through the two tables recently posted. They are "Sponsor", "NHS Provider", and "Neither". Note that neither FDA nor IEC nor PEI nor UKFDA are among the apparent options. So not sure that those are not included in "Sponsor" in the first table, but more accurately described as "Neither" in the second table.
But it is not clear to me. I still hope you turn out to be right and the hold was initiated by NWBO.
"I am hesitant to get too involved."
I think that one safe piece of advise to any GBM patient is to seek out all possible genetic testing that might be useful to select a treatment, or trial, or compassionate use group with. It might be even more useful next week or next month. Just better to know.
I don't know how much testing is available and what the reimbursement is, but it is worth looking into. Look at all existing GBM trials and the relevant genetics, and you want to find at least the info needed to optimize you odds within each one.
Methylated or not is probably useful. That probably means the tumor, but they should find out if the broader patient genetics is enough of a clue, if the tumor is not available for such analysis.
Those 4 GBM groups are important. The Classical, Neural, Pro-Neural, and Mesenchymal.
And there are other trials targeting highly expressed (self?) antigens. Not sure why in the world they would work, but since they might work, should test for those. There should be a GBM panel available. Maybe not this minute, but maybe next week. Call Biden's Moonshot people and ask what a GBM panel would be. If there is no such thing yet, ask why not.
Yes, I had forgotten this Ph 2 history for L, but that is what I was thinking of. Thanks RK for the review and exwannabe for the summary.
Reading the SEC filings that RK provided, it is not totally clear if there were any patients in the first attempt at a phase 2. They say they screened 50 and had difficulty actually enrolling... but don't say that nobody enrolled. I will assume you are right and those first few patients, if any, are not charted. Clearly they could not be part of the ph 3.
This does all tell me that the FDA was not being unfair in insisting on a crossover for phase 3. But no fingers pointed from me at NWBO either. Just a very difficult and somewhat sad situation; a situation spoken about by Biden in his address yesterday.
"You mean the Phase I/II. No crossover. "
Would you please elaborate?
Phase 1 generally has no control group so crossover not an issue.
Phase 2 = 2 parts or just 1 phase 2?
Ok. Maybe there was only 1 phase 2. I thought there were 2 parts to it, the second including some changes. That the first was unblinded at the end, but the second remained blinded and was pulled into the Phase 3.
The issue is the FDA forcing crossover. If the reason they forced crossover in the phase 3 was because such existed in the phase 2 (that NWBO wanted to include in the phase 3)... then I have been off base to be so upset about that issue. That would be totally understandable of the FDA.
You are saying that Phase 2 did have crossover. Did the FDA insist on it in the Phase 2? Seems unlikely.
"Joe Duarte, M.D., calls "ALPHA CELLS". Well, this is just his term for dendritic cells"
That is apparently a standard BS pitch these days. You give an existing technology a new phony name and then list every cool thing about it.
I saw a sales pitch for solar cells recently where they made up some new phony name for the standard silicon solar cell, then called it a major breakthrough that will have the oil companies on their knees in a few years... and then listed all the nifty things about solar cells. I wish I could remember the name they made up. It was pretty clever. Had me excited for about a paragraph.
I want to underline a key point in what you wrote. If and when they reveal positive trial results for either L or Direct, they will be in a very different legal position regarding both defense and offense.
Technically, that shouldn't be the case; A damaging false statement is still a damaging false statement, and improper business actions are still improper, but it does matter whether the underlying drug in question works.
People don't care much if a bad drug got hammered along the way, even if the hammering was illegal and without true basis. But they will care a great deal if a treatment for brain cancer with demonstrated efficacy was put through a nearly impossible gauntlet of lies from multiple sources. Or a treatment for all non-operable solid tumors. And the courts might look the other way, to some degree, regarding minor technical violations at NWBO if their mission to treat cancer validates itself.
They might as well wait for some efficacy feedback, which I believe may come sooner than the end of the trial.
Flipper, anyone: DCVax-L P2B had crossover?
This is a very important question in my opinion. I don't see that trial on clinicaltrials.gov... and it is so much easier to tap into the brain-trust here.
Looks like they are key in the feds "Moonshot Initiative". Just saying they had their own "Moon Shots Program" long before the Feds.
The Feds program started less than 5 months ago, in early 2016.
MD Anderson's "Moon Shots" program started almost 4 years ago:
http://www.chron.com/news/health/article/M-D-Anderson-launches-3-billion-fight-against-3882246.php
"M.D. Anderson launches $3 billion fight against common cancers
By Todd Ackerman Updated 8:06 am, Friday, September 21, 2012"
"The University of Texas M.D. Anderson Cancer Center on Friday will announce an ambitious initiative to dramatically reduce the death rates of eight common and difficult cancers."
"The $3 billion effort, dubbed the Moon Shots Program, will bring together large teams of researchers and clinicians to mount attacks in the next decade on cancers that annually account for nearly 750,000 cases and more than 260,000 deaths. Those figures represent nearly half of the nation's totals in both categories."
http://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative
"During his State of the Union address on January 12, 2016, President Barack Obama announced the establishment of a new National Cancer Moonshot Initiative to accelerate cancer research."
I believe that MD Anderson had coined the phrase "Moon Shot" for their own programs, long before the feds. Not sure if this is a coincidence on the feds part or if that is where they got the name.
My iffy recollection and assessment is that MD Anderson had created their own "Moon Shot" program a couple years ago to divert attention away from some dirty dealings that gained a lot of press.
Thank you Flipper. The Direct situation was my only big concern, and that does serve as a very good reason for them to wait.
Further, "but I'm not a patient, and therefore I have no right be impatient"; in addition to having a nice ring to it, makes a great deal of sense.
Regarding ASCO and news about upcoming combo trials: I don't think that is the kind of thing that would normally be part of an ASCO presentation to begin with, but further, the partner BP's have control of when such a partnership can be announced. At least that was recently the case with another company's BI combo trial with a BP.
Very hard to say when they might finish those negotiations, but I could see a BP wanting to wait a while after ASCO to announce such, even if the negotiations are really finished. Of course a BP would want the attention down the road if the results are good, but why draw attention away from the successes they already have, which is the usual focus of ASCO.
Well, there was a lot of buying today. Maybe they did put together some good material. Legally couldn't be new material, but could be better presentation of old material.
Whether any lackings at ASCO should be embarrassing to the company depends on details we just don't have about the DCVax-L trial. If that makes you assume the worst, I don't blame you. But on the efficacy end, it makes enough sense to satisfy me, that the hold and whatever else might be going on are likely in the hands of the regulators and something NWBO just can't talk about.
The internal investigation and other legal matters do not relate to ASCO. The only gaff here specific to ASCO would be if they did not have any follow-up data for Direct. Why would they not have that if it was good? And if they did present such, wouldn't they have been required to PR it by this morning? Unless... it was presented after close today. But that seems unlikely.
So probably no improvement in the data for Direct as it matured. That doesn't mean it won't be a miracle drug when in combo with a BI, but it is still disappointing to me.
Sorry to all the longs for my jokes about NWBO presentations at ASCO, but it is painful to go through ASCO with the staff all huddled in the Cone of Silence. Very awkward.
They should be out bird dogging chicks and ban... . No, that's not it. They should be bragging up clinical results. That's it!
Why not bragging up DCVax-Direct results? Maybe they did.
Lack of a big news release as ASCO doesn't bother me much given my assumption, at least about L, that they can't talk right now.
There are other things that worry me more.
Coley's Toxins were front and center in Joe Biden's speech. Not a lengthy discussion but front and center and one of the few places where he expressed frustration with the status quo.
Flipper must have enjoyed that a great deal. I remember when he first started talking about Coley's Toxins years ago.
Bodes well for NWBO so to speak. The focus being immunotherapies... but not including the Blockade Inhibitors.
Thank you Sharpie.
"Live Stream: Vice President Joe Biden's Moonshot Address:
https://am.asco.org/virtual-meeting-on-demand/presentation/biden-live?platform=hootsuite"
Re ASCO: "And what of their content etc?"
Loose Lips Sink Ships... so they probably stuck to charades. However, I understand there was one presentation; a very popular one at that!
Maybe such a combo trial alone would not be enough reason to get super excited, if trial data from the DCVax's didn't strongly suggest that often a strong immune response does get generated as a result of DCVax, but it sometimes blocked by the Immune Blockade functions. An immune response that was not generated by the body alone, without DCVax. But the trial data does suggest this. See Dr. Prins video.
As monotherapies, the blockade inhibitors (BI's) have horrible side effects at the dosages needed to be effective. These side effects occur in about 25% of patients, which is about the same number of patients where they are strongly effective. This makes them a miracle drug for patients who's chances of remission were very low, ie much lower than 25% without the BI's, but it makes them inappropriate for many other patients. If the DCVax's do generate a strong immune response, as data presented shows, then this might allow the use of a smaller dose of BI's in combo trials. Maybe a small enough dose to reduce the number of side effects, yet with synergy, increase the efficacy. This is the hope, and it is totally rational to estimate the chances that such will prove out are high.
DCVax-L and DCVax-Direct are two of only a few therapies that generate T-Cell responses targeting neoantigens. These few therapies may prove to be the only cost effective therapies that accomplish this critical task. There are "T-Cell" therapies that do this by extracting and replicating T-Cells from tumors, but those therapies are substantially more expensive than the projected cost for DCVax-L, and much much more expensive than the projected cost for DCVax-Direct.
There is every reason to believe that the chances are high that the combination of DCVax-Direct and a BI will prove to be the next miracle cancer cure, with the most recent being the BI's themselves, and perhaps the individualized T-Cell therapies. DCVax-L may prove as effective or more effective as part of the combination therapy, but the cost is not fully known, though again, I believe it is safe to estimate the cost to be much lower than for the T-Cell therapies.
One of the concerns about the performance of the DCVax's is crowding in the DC pathways and lymph nodes due to the very large number of DC's created that carry self-antigens for every neoantigen for presentation to the T-Cells in the lymph nodes. But DCVax-Direct DC's are not injected in the skin near a lymph node or a few lymph nodes. They are free to travel from the tumor along whatever path they chose. They likely distribute widely, and might distribute relatively uniformly to all of the 500 lymph nodes in the body. That is a huge amount of reduction in crowding for each pathway and each lymph node. Further, the mfg process for the DC's for DCVax-Direct was already relatively inexpensive, prior to recently being automated. Unless you believe the unlikely allegations that the DC's don't survive the freeze thaw, you may have a limited time to get your butt out of shortsville.
I get your point now. But maybe the PEI is more inclined to check out such patent issues. They seem to be more inclined to check out lots of things.
And maybe there was some other similar German patent in the cue and thus in contention, or an existing patent that was mucking up the works without the German patent nod.
"Quote:
the humerus is the bone in the arm (under the biceps and triceps
Isn't the triceps head "under the humerus" while humerus is under the biceps? Otherwise, they wouldn't work as well as they do."
Actually, if you are standing, they are both alongside the humerus. If laying on your back, with palms up, the bicep is on top and the triceps is on the bottom. If laying on your stomach...
He really is an M.D. spartex, a radiologist that knows a great deal about anatomy, but more importantly, cancer. Give him a little credit.
Revised: "Not sure if you are saying mfg is the cause of the hold, but, I do not think so. And, if not, what is the relevance of this discussion? I really appreciate the majority of what is posted on this board. But, I have to say I am just not following the logic of the mfg patent stuff as patents do not typically play a role in this area and certainly do not play a role in timing of use of processes, FDA approvals do, and, FDA approvals do not interfere with patents either, they are separate processes unto themselves with the FDA approval the more important of the two as mfg patents tend to be relatively easy to circumvent, which is why it is not a prevalent practice, though in biologic processing there are more due to the relative newness of the technology, which is starting to become much more widely understood and used."
Oops, hit "update message". Below will be my response in a couple minutes.
My response to a question not posed to me, but I have no manners.
I may not be understanding you, but it seems to me that if regulatory approval of a phase 3 depends in part on demonstrated ability to handle the mfg volume required if the drug becomes part of SOC, then any mfg process that is important to the ability to handle such volume would be relevant for approval. If so, then the patent for that process would matter. If the FDA et al are going to concern themselves with the practical, ultimate realities involving mfg volume, then a related patent would have to be part of that reality. Easy to circumvent? I don't know, but the attitude that the FDA reportedly takes with this kind of issue would not seem to be so relaxed that they would allow the assumption that you would find a way around any patent blocks.
That said, they reportedly already had the patent in question for the US. So it gets mysterious for other reasons than I think you are pointing at in your post.
I think Pyrrhonian and Highwayman should both take into account that Pyrrho is a major league competitive chess player. Not sayin anyone needs to bow to the smarts that implies; rather, saying that competition is in his blood. Intellectual/smarts competition. For that reason it must be very tempting for him to try to support the broadly unsupported view. To take that challenge. That puts him up against an entire team of people. Here with the many longs on this board, that unsupported view is the bear position.
With regard to multiple possible reasons for the delays. Not sure this addresses a hold, per se, but maybe the delays during the hold...
Just recall that one of those competing therapies that you reference in the statements by NWBO, was Celldex's GBM drug. And though it fell off the map, it was likely a major complication to any review regarding efficacy, for many months.
"I was told very specifically last year that NWBO decided to stop screening in the other countries because they did not want to give unfair advantage to any group while waiting for a response from regulators on the data they were submitting."
I am way back in the posts.
Was it your impression that they didn't want one country advantaged for ethical reasons or because such an imbalance would be a problem for regulatory considerations / approval considerations?
"$170mm plus in costs went from NWBO to Cognate, and $100mm of that in cold hard cash. Meanwhile, Cognate DOUBLED in size for just $9mm??"
Do you have a breakdown of how much of that was actually for property/real-estate, if any, and how much was for to R&D or V&V, for example? Neither of these other large expenses necessarily buy NWBO property, or even finished goods automated mfg equipment. It buys the plans and validation of a design and build, but these might not include the actual build. R&D and V&V output could be just paperwork and computer files.
Was the money for property/real-estate, if any, a loan? A loan would make sense, and would allow ownership to be Cognate's, sort of.
"The fact that they continued to enroll should rule out a mfg issue that caused a hold on clinical product supply. "
Oh yeah. I forgot about that.
"Partial Clinical Hold: A delay or suspension of only part of the clinical work requested under the IND (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND)."
Wasn't there a major focus by the FDA on injectibles contamination lately? I wonder too if maybe NWBO did not implement the new DC mfg method in the US and other trials, where they had patents, perhaps waiting for Germany so that the countries would stay uniform, and any procedures for validation could be debated once by all the agencies, and agreed upon, before starting that validation.
I think LP said they had started using the new DC mfg process for DCVax-L... but maybe that is not exactly what she said. Have to find that language. It was posted yesterday by somebody.
Restated: So... maybe NWBO had not implemented the new sealed DC Mfg process yet, anywhere for DCVax-L, and was waiting for the German patent, when this big FDA focus on injectibles contamination came about, resulting in inspections of all such facilities, and they dug up a problem at Cognate, and the resolve by NWBO was to implement the new sealed Mfg process, but they were waiting for the German patent so that validation could be agreed upon by all parties. Ie, maybe Germany did not want to participate in such a discussion up front because the issue was moot without the patent.
If so, there would be two separate parts to the delay. First the FDA calling a halt either to allow inspections or because of a negative inspection result, then the further delay by NWBO waiting for the German patent to initiate usage of the sealed DC process worldwide.
Yeeeeaaaah, that it! That's the ticket!
Is this what RK or Sentiment, or CherryTree already said?
You have a good point. Well, I did back pedal pretty quickly.
Not that I want to change the subject from what an idiot I am, but this statement that you brought up about NWBO looking forward to the upcoming Direct Phase 2 trials makes me wonder, once again, whether those trials will include BP partners with Checkpoint Modulators / Blockade Inhibitors.
The main argument against that has been the statements in the Prins video that strongly suggest DCVax-L will be trialed soon with these BP's and adjuvants. But why would this exclude the possibility of the same relationships and adjuvants for the Direct trials?
I remember LP talking about adding legs with BI's for the phase 2 Direct Trials. I don't see any reason to expect that to not come about.
------------------
"may not be able to complete the planned enrollment in this trial." I suppose RK could (and probably did) argue that this is consistent with not being able to finish enrollment in Germany if the patent was not granted.
It doesn't say "would not be able to enroll the planned number of patients for the trial", which they could get from some other country, "it says may not be able to complete the planned enrollment". Maybe that just means the further patients planned to be enrolled in Germany. That would make total sense for the language.
Then Pyrrho would, and I think did argue that it wouldn't make sense to put all countries on hold due to an issue in Germany....
Then RK, and maybe Senti would, and maybe did argue that maybe they want these further patients to all be from Germany... for some reason. I think Senti argued that the Germans may want to see a slow ramp in use of the new DC technology, and to accomplish that, they want all remaining patients in the planned trial size... or did I argue that... whatever. It sort of fits.
Nothing fits well, and it sort of fits.
(Late Corrected Quote) Sorry Sentiment, I thought it was Pyrrhonian that said he thought the hold was by the sponsor, not you. I thought I was reading his post, not your's. It was unexpected that he would say that, but thought it was him.
He reposted the relevant section of the the 10K this morning in post # 63157.
Quote:
Our Phase III trial of DCVax-L is on a partial clinical hold for new screening for enrollment. We do not know what will happen with this partial hold. Although we have over 300 of the planned 348 patients already enrolled in this trial, and they have continued to be treated without interruption, we may not be released from the screening hold and may not be able to complete the planned enrollment in this trial.
"But I do suspect the screening halt was initiated by the sponsor."
I have thought that was probably the case for some time. Also hoped that was the case. But you reposted the relevant statements from the 10K this morning. Those statements seem to clearly indicate that the hold is not by the sponsor. That is how I read them anyway. I don't want to reprint them because they are kind of scary, and a big part of why I flopped for a while today. Not that they are new, but they hit hard this morning for some reason. Maybe in conjunction with your arguments that the hold could be imposed by the regulators.
But as I said; though my "experience" is pretty much reading posts on this message board, I don't think the regulators often hold for futility. I think that is usually the sponsor. And again, the 10K language seems to be clear that this hold was not called by the sponsor.
I also retract my prediction that good news will come tomorrow morning before opening bell, making the Russell wish they had kept us.
I did some research and learned that tomorrow is memorial day. RK and Sentiment are not the only ones doing research here.
Flipping my flop further: This morning I had agreed that Pyrrhonian's guess that the trial was on partial hold due to essentially futility, fit the knowns too well to ignore. Then I backed off a little bit. Now I am backing off more.
I don't think it would make sense for the regulators to intervene for futility with the trial almost fully enrolled. My understanding is that they don't typically intervene for futility anyway, but to do so with the trial almost fully enrolled would seem pretty strange.
Anything other than futility would obligate them to stop treatment for all patients.
So... I am back in the long saddle. Now everyone can buy back the shares that they sold this Sunday morning.
I think someone else argued the same earlier today. Sorry if I am repeating. I am sure this same argument has been posed many times in the past months.
No, this isn't just another cancer treatment. This is an emerging class of treatments where BP is not in the forefront. There is so much learned every day about these immunology details that the chances this basic approach proves worthy is extremely high, even if the current versions do not show efficacy, yet BP passed on the entire class of therapies. They very likely did so because they thought it would be too expensive, not because they thought it would never work.
I think cost matters a great deal. I'm not saying that being worried about that is evil. But that is for the insurance companies to deal with. I understand why they would not want to be in the position of having tell people that a demonstrated therapy/possible-subgroup-cure is too expensive... but that is how this works, if in fact, the costs prove to be very high. I think they, long ago, planned to nip this oak tree in the acorn, and I think that is what might be going on now.
Let me soften my position here in agreeing with Pyrrhonian. I just agree that it makes a great deal of sense as an explanation for what is going on. At the moment I don't remember enough details in the counter-positions, including RK's recent revelations, to weigh them properly. But this simple position Pyrrho is taking does look like a real possibility.
But if so, let me re-itterate that I think the chances are very high that the classic BP influence over the FDA is part of what is going on. And further, I don't just think that the men on the moonshot should look at that, I think they will look at that.
It may be a very unfortunate series of events for BP and the Insurance companies that Joe Biden's son died of brain cancer and then Joe Biden was put in charge of the moonshot program, all as this standoff between NWBO and the FDA/BP/The Insurance companies might be unfolding.
While Pyrrhonian's guess seems the simplest explanation to me, the other issues listed here also seem the simplest views. The near obvious.
Maybe some of what you are saying makes sense, if in fact the reason the FDA insisted on crossover in the P3 was because NWBO had such in the P2B and wanted to include the P2B. I would like to check that out a little and give others a chance to respond.
But a couple of points. 1) By including the P2B, they did gain a large advantage in having a very long tail for the trial, which they may have properly anticipated as being important to demonstrate efficacy. 2) I don't think that a subroup as fundamental and universally recognized as mesenchymal or (mesenchmal + methylated) should have to be pointed to in advance to be a point of discussion in post analysis. That should only be if less than SS was to be considered within that subgroup. Hopefully that is not the situation.
Further, you start out saying:
"The trial was designed as a smaller P2 with PFS as the endpoint and not powered for OS."
But P2's are not powered for anything, or they would be P3's. So what are you talking about?
"Who knows if the FDA suggested or required the cross-over, but it hardly matters."
I know. I know because the lead investigator in the trial says so. You talk like there is no way to find out. There is no way for me to find out, but those communications get documented. It's on the FDA's permanent record! Their permanent record!
You think it doesn't matter? You think saying that it doesn't matter just makes that so? Of course it matters. It obviously matters.