I ordered Beartraps notes from April 27, 2018. (I'm not certain where note 5 is)
[Note 1]
This is the first of the verbatim notes from the meeting. I skipped a few repetitious phrases and may have missed a few words, but without going back over and over many times this is the first question. Verbatim notes from Apr 27, 2018 meeting
Linda: answering Senti's question about publishing article vs. just getting info out there: "Publishing of interim data in a science journal by its nature is a long process....it took longer than we expected, it took all the way until Oct. to take the first step of submission. We get that it feels like forever, and I can only tell you it feels like forever to us, but we actually want that data out there. But the actuality is its only been 6 months. In the world of academic journals, thats pretty much what you're dealing with. It's a reasonable question: at one point does the value of being in a learned journal outweigh the value of just getting the information out there. We all know, we get attacked for everything. We're damned if we do and damned if we don't. If we stay the course and we get it out in a learned journal, that would be great, of course its been an agony for all of us and I assure you it is for us, too. We do understand what agony it is for you all. That's one set of pros and cons. If we, find other methods to put the information out there, we can certainly do a press release. There are pathways to put the data out there not through a learned journal, then you know what will happen: the parties who would like the company to be dead and never get to the finish line, will jump all over us and attack us, and try to undermine the credibility of the data, and the importance of the data, and the value of it. So its kind of an agonizing choice for us. We're trying to balance what is best for the shareholders and the patients. I would just say that we feel its appropriate to have stayed the course this far , we wouldn't change that, and we feel it's appropriate to stay the course a bit longer, but that balancing act she's asking about is a balancing act that we think about and continue to think about. We're not unaware of the tradeoffs.”
April 27, 2018 note 2
[Question] What you can tell us about what you see the approval process looking like?
Linda: “There's no way for us to really know what the pathway possibilities are going to be until we see the full picture of the data. Right. And one of the reasons we are persevering to see the full picture of the data is because of the full value when we unblind and we go down one of those pathways. It certainly has been encouraging to see some of the recent policy announcements by the regulators in the USFDA, accelorated pathways and so forth. There's no way to know what will be the status of those policies and whether they will be applicable to us when the time comes or won't be, but it's certainly is an encouraging environment, and I really can only say, with any regulator, the pathway depends on the data. If the data is really compelling then you have more pathways. I can't really say more than that right now.”
April 27, 2018 meeting; note 3 Les on pathways to approval: The pathways seem to be growing...in the sense that regulatory authorities across the spectrum where we're operating ...and the right to try law seems like it's getting closer and closer to being inacted and we're well situated even before it's even approval. Those are all positive develops that before we're done we can't be sure, but it seems we're getting better on all fronts.
Investor: Still collecting events? Yes. Any guidance on how many patients are alive?
Linda: We don't collect just a single data point. What we have said is we are going to do another data collection. ...Multi-month process. ...We are in the process of getting underway with that. This is in alignment with past processes. You have to make a physical trip to every site and getting the raw data, then you have to resolve all of the queries just to have the raw data. That's all done by the CROs. The company has no participation in it. Then the raw data goes to the independent statisticians.... and they tabulate it. They make the tabulations of median overall survival and other data slices. In terms of the number of patients alive, we find that that in isolation doesn't tell us enough. We want to see the full picture; we want to see the whole context. We'll get that information as part of the data collection.. We're in the early stages of it (data collection.)
April 27, 2018 meeting note 4
Data read where do we go from there”
Linda: the range of possibilities is the range one would always have. If we happen to have the happy circumstance that the range of patients are still alive, that will help us make a decision about which way we will go.....What we are trying to get to, and all of you should want tdo see, is what is the full performance of this product, what is the full performance of this technology? And we've had discussions with our scientific board, wonderful, expert opinions in the field. One of the concerns of our advisors is don't unblind too early. There are multiple examples in the past unblinded too early. The pressures to unblind are enormous, enormous. We totally understand and how much ..Shareholders want to know the information. We want to know the information. It's like waiting to open your presents on Christmas morning. The companies that have unblinded too early have really hurt themselves and their shareholders, because once you unblind, you will never know what was the full performance of your product....As an immunotherapy, what everyone wants to see is that long tail of survival. The medians are important, the early events, that's important. But in the world of immunotherapy, the big focus and the big excitement is what is that tail? On the other hand, we're not going to go forever, we're not going to wait til the last patient is gone, we're in a continuous advise mode, and we'll continue to get advise from our investigators and our scientific board. Now, I can't give you all the specifics, except to tell you that is what we want to achieve. We want to see the full picture.
We don't have a formal or fixed plan, but given the process takes 3-4 months. There's nothing to say we can't turn around and do another data collection in the fall. It's a big burden on the CRO and expenses, because it's such a big exercise, but in terms of going through this exercise about once a year, is giving us the periodic update that's been helpful for us.
Question: Linda Liau about a year ago mentioned the long tail was about 20 to 25% of the 331? Has she repeated it. Linda: I wasn't aware that she used that number in the video. Question: If a patient dies, are they required to tell you?
Linda: They don't tell us, they tell the CRO. And that information goes to the statisticion.
Question: It's logical you could have a speaker get up around June 1st as ASCO and give the new data?
Linda: I can't comment on that one way or another. It's technically a possibility, but I can't comment on whether that fits this year's timeframe. Les: and you can't cherrypick it.
Linda: We haven't said that, and right now we're particularly focused on finishing the process of the publication of last year's data. We want everybody to get a full picture of what already exists. Question: Wouldn't the pub want to have this year's data? Les: There's a time frame: scrubbing, and studying and peer reviews. If we got it tomorrow, it wouldn't be in a publication in a couple weeks. It'd be like a year. Linda: Once you choose to go down the path of one of these scientific publications, you're in a long-term timeframe. There's nothing unusual about where we are today with the data set or this publication. It's only 6 months since our first submission step. That's absolutely par for the course in the academic world as far as I understand. So, that's where we are.
Me: Endpoints and what the FDA would accept or not accept? Are you in contact with the FDA and this is an adaptive clinical trial?
Linda: I don't believe the level of adaptive clinical design is applicable. Dr. Bosch is the one to talk to about trial design. (shortened)
Me, shortened: Can ou address some of the potential complications with the endpoints? Has there been problems with the whole pseudoprogression caused by our treatment? The second endpoint, the crossover, has it complicated OS. In your dealings with the FDA have you talked about it, have those two endpoints been compromised?
Linda: In the whelm of brain cancer pseudoprogression has been an extremely well-recognized phenominum. Over the recent years, not only has it been recognized as a regular phenoninum, as many as 30% of brain cancer patients have pseudoprogression, and methodoligies have developed in the field at looking at pseudoprogression. I think there's a growing understanding about the whole subject of pseudoprogression. I can't say sitting here today what the FDA's perspective on a particular aspect of pseudoprogression on any particulator trial, ours or anyone elses, would be. That's going to be down the road. I can only say I wouldn't personally describe them as complications. They are just part of the brain tumor landscape and treatment landscape. Whatever discussions we've had with the FDA or we may in the future, I wouldn't be able to discuss them publicly, it will ultimately come out in the process. All of us are going to have to wait for that stage.
Me: PFS progression, did we find people who had not really progressed but because of pseudoprogression, were put down as having progressed?
Linda: I'm not sure where you're getting that from ...us going through this or that process. We haven't said anything publicly about PFS or progression.We haven't talked about having gone through this process or that process. We haven't spoken about the subject yet. That's something will be... that lies ahead, that we will be speaking about in the future. But not that I'm aware of, we haven't spoken about it yet. So you have to stay tuned.
Note 5???
April 27 meeting, Note 6
Les: I think its important for everyone following us, to take a step back and look and say, it can't be a bad thing if everybody getting the vaccine is living longer. So it becomes a question that with all the new policy initiatives at the FDA and overseas, how do our facts fit into this and as Linda says, it's still a work in progress to find the exact right slots, but the bottom line is if we have something where everyone who's had the vaccine is living longer, that's a pretty good thing. We shouldn't lose sight of this in the context of all the rules that used to be, and might be and are gonna be. People on the otherside of this would like to use that to camoflauge the reality of what may be unfolding. Linda interjects “it's a maybe and we don't actually know for sure.” Les: We don't know for sure. Question: about European manufacturing. Linda: We record in our filings that we are consolidating our European operations in the UK. We're in the process of doing that. It's going to be a better program for us. Question about unblinding and time it takes. Does it take up to 8 months? Linda: In terms of unblinding, when we do a final data collection and we get to database lock, it's going to be a bigger process. I don't personally believe it will be that long (eight months). It will be a bigger process than these data collections.
Question: Would you consider in the future letting people listen and call in? (She really didn't get a chance to answer this, but there was at least one shareholder who was over identified as a number, listening in on the talk who was able to communicate with us. He complained of not being able to hear a question at one point.)
Flipper's question asked by an attendee: Will you stick with the current NICE approval timeline? Linda: Obviously I can't answer that in a public forum. We have to put it out as material information that we have to put out to everybody.
Question: What can you share that hasn't been asked that doesn't put you in a legal issue?
Les: I think the thing that gets lost in all the cacophony of lies and shorts and coordination of micro-malipulation is the simple proposition of going on our website and finding all the data on all the trials we've done, is pretty impressive and I think that's why you're here. I think it gets lost in this frenzy about “what have they done wrong again and how can we smash them another way and tell some more lies and create this fallout?” Go and look at the phase I, and phase II and what we know about Phase III, and information arm, and all of it is really quite interesting. Is it done yet? No. Is it encouraging? Yes.
Question: What's new that isn't on the website?
Les: It's nearing the end and you have to be even more careful. (Not hearing anything...) it doesn't mean it's not happening. It just means its not ripe. We're under such scrutiny, that until it's really clear and will be undeniable, we have to be really carefu about it.
Linda: I can't think of anything we can share with you. As excruciating as it is for you, it's every bit as excrutiating for us. I'm sure you saw that I put $4.4 million of my own cash. I didn't do that to just have a bonfire.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
