RE:RE:RE:Target Engagement Excellent questions, MineDigger. Let me try to knock 'em off, one by one.
1) Thanks for the summary jd, but what about how far Bioasis have got with this?
No company releases much detail of internal studies. Pfizer, for instance, has about 100,000 employees world wide. No way we're going to learn much about what they're all doing. The Bioasis corporate presentation has some details and timelines in it. Explicit and implicit details can be derived from this document. For example, the timeline for xB3-001 shows a pre-IND meeting with the FDA in October. I would think it safe to assume that considerable information and data from studies would need to be known in order to go into that meeting. As with all pharmaceutical and biotech companies, Bioasis will have to make some decisions about how much detail about study results to release to the public.
2) You talk about studies as "designed", which tends to suggest they have not yet started?
All studies are designed to generate maximum informational return for the effort and cost. The studies at Texas Tech and with Scarpa were all designed to maximize this return on investment. The word "designed" in no way is meant to suggest that studies have not started when, clearly, so many designed studies have already been completed throughout Bioasis' history. However, it is not my place to discuss any aspects of the timing and nature of Bioasis' ongoing and planned studies.
3) And what about previous work done? Didn't any of that require biomarker selection and use already?
Yes, previous studies did assess some biomarkers but because these studies could be considered proof-of-concept studies with Bioasis having no intention of moving towards human clinical trials, the studies were never done in the robust manner required to enter human trials. Bioasis never had internal development programs (the forerunners of a drug pipeline) with human clinical trials planned until Mark Day and his team came on board.
4) And then after the "Non-human primate and rodent studies" there will need to be a whole new set of human studies?
Yes, you're absolutely right, a whole new set of human studies will be required, but these studies are more usually referred to as human clinical trials. The timing of those is indicated in the corporate presentation.
5) Does the raising of this new area of focus imply that more work than anticipated will be needed to get other stated objectives achieved (and what is the time cost, if any), or are we just getting background on one hitherto undiscussed part of the existing plan?
I think these plans have been articulated quite well by the company. The corporate presentation even gives timelines. Our most recent financial report provides some insight into the costs. As far as this being a new area of focus, it's only been a year, so I suppose it is. Much of the company's plans was announced in a June 14, 2017 press release with further details coming out since then. All projects have critical paths to completion and I would think that the engagement of WuXi is very telling in that regard. The corporate presentation is a serious document. It's what speaks for the company on many of these questions and it needs to be studied carefully.
The answer to your question about whether "more work than anticipated" may be needed is that it's possible, maybe even probable. Each study provides information and data that inform the choices to be made for the design of later studies and clinical trials. But that's why Bioasis has put together such a stellar Scientific Advisory Board (SAB). I don't think that people pay enough attention to who sits on that SAB. Appointment to the SAB is not for optics or stock promotion. It's the SAB's job, in concert with the company's scientists, BoD and executive, to ask all the right questions, to develop scientific and clinical plans, to anticipate the very things that you are asking about.
Bioasis is functioning at a very high scientific level. There may be dozens of people working on this, a few full time, others appointed to the SAB and BoD, and still others working on projects at WuXi and other contract research organizations.
Slowing this freight train down is not an option. And make no mistake, this freight train is headed to a destination. Bioasis will produce results, good, bad or indifferent. This is what biotechnology is all about!
Just imagine if we're on the side of the angels on this. Brain tumors. Glioblastoma. Neurodegenerative diseases. Metabolic disorders. All needing drugs to be transported across the BBB and into the brain. ANY news of advancement in the treatment of these diseases will make headlines.
Let's get the science done, the things we need to go to the FDA and to get into the clinic.
jdstox