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08/05/19
14:46
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Originally posted by JB1975:
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"Why would we be looking for someone else to compete regarding the manufacturing?" My perception (could be wrong but it's based on a Fujifilm presentation from January this year which I believe you brought to the attention of this forum) and is supported by Fujifilm's purchase of businesses with manufacturing capabilty (of cells) and expertise (cell technicians etc) is that Fujifilm are planning carefully and intending to operate strategically to try to own the global manufacturing space for the production of cells for therapeutic purposes before the rest of the world gets ready. My percepton is that that part of the value chain - owning large scale facilities is likely to be capital intense and that only a few largish players will have the capital to play in that space globally when it comes to the production of cells at the scale required for commercial/clinic use. "The article is not talking about manufacturing ." True- I'd little interest in the article other than it contained a quotation attributed to Ross. "Therefore jumping from manufacturing cells and the "fast track" P2 option availability to then mention a possible limitation of partners for our product does sort of miss the subject ." It does. Sorry about that. I could have been clearer. I'm thinking about Ross responding to Fujifilm (and my interpretation of what Fujifilm is probably on about) not really about the article. " You don't need to manufacture our cells in order to take up a licence from Cynata.Manufacturing :" I understand that. "So far Waisman Biomanufacturing has been our manufacturing partner for the iPS to MSC part..... no need to do that yourself in order to take up a licence from Cynata ." True but for a producer to provide cells at scale to clinics they have to have a means of producing those cells in the appropriate scale. So a licence from CYP for an indication without an identified means of scale production wouldn't make a lot of sense commercially in my opinion. And at this stage (my research here is tiny) I don't believe there are many cell producers for clinical use existing because there hasn't to date been a need for that. "... officially naming a potential partner before anything has been signed - I wouldn't call that common practice ." Neither would I - it would be very unorthodox. And there might be problems with Ross naming just one especially if he was in negotiations with that one- but I'm not looking for that - I'm looking for an indication that in general terms he understands the emerging global marketplace and won't be sitting like a stunned mullet with no plan (no-one else he could go with the talk about phase 2 trials with Japanese regulators) if Fujifilm is playing a tactical game and seeking to freeze him out. If he had the knowledge base to back it up Ross might say something like - in the event Fujifilm elects not to pursue the GvHD option in Japan with us it would seem that X, Y or Z might have the capabilities we need to partner with us in a) Japan or b) the world for GvHD specifically. He could even say that identifying X, Y or Z did not mean they were or were not in negotiations, that he only mentions it to show he knows there are potentially other options. I respect that you do quite a bit of research - can you name a competitor or competitors to Fujifilm in the global (or Japanese for GvHD in phase 2 to clinic in Japan) - you don't have any restrictions of the sort Ross would have? I haven't done enough research - I believe there would be companies that would be potential competitors (in manufacturing cells for clinic globally and perhaps in Japan) but aren't yet because the manufacturing need hasn't arisen yet. So that if Fujifilm has a plan to capture much of the global value in the future regenerative medicine space in all indications by controlling the manufacturing or most of it globally by acquiring potential competitors who could be scale manufacturers - that is probably not in CYP's interest - it would be better for CYP to have a variety of players that could produce cells at scale for the clinic because then they could get better commercial deals as the manufacturers wouldn't have a monopoly or oligopoly forcing CYP to deal only or mainly with them. This might be rambly - sorry if so - bit time pressed but thought you questions were fair and wanted to respond. Appreciate the research that you post.
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Your suggestion: "If he had the knowledge base to back it up Ross might say something like - in the event Fujifilm elects not to pursue the GvHD option in Japan with us it would seem that X, Y or Z might have the capabilities we need to partner with us in a) Japan or b) the world for GvHD specifically. He could even say that identifying X, Y or Z did not mean they were or were not in negotiations, that he only mentions it to show he knows there are potentially other options." Are we only talking about the manufacturing side of it, licencing our product CYP-XXX or a combination of manufacturing and product licencing? As stated in a interview in 2016 (best example I could find) by Stewart Washer: "TLSR: Is that a complex manufacturing process? SW: Making MSCs is low tech, requiring only basic cell-culturing techniques. We can grow them in flasks, or even bags. The high-tech angle is the patented cell culture technique to turn the unlimited iPS cells into usable MSCs."https://www.streetwisereports.com/article/2016/02/03/advanced-stem-cell-manufacture-saves-lives-and-prints-money-stewart-washer-of-cynata-therapeutics.html Reading that, you would assume that any of the big bio CDMO/CMO should be capable to adapt the Cymerus technology. Here are a few links:https://www.genengnews.com/a-lists/top-15-bioprocessing-companies/ https://www.pharma-iq.com/manufacturing/articles/top-10-medical-contract-manufacturing https://www.outsourcing-pharma.com/Article/2018/10/22/Top-5-CDMOs-hold-15-of-the-market-as-industry-consolidation-is-expected-to-continue Examples of licensing and T/O transactions have been provided in previous asx announcements and investor emails. Bear in mind, FujiFilm, Hitachi, Asahi Glass, Mitsubishi, Samsung - they all came from a different industry and are now in the biotech sector. Whilst constantly repeating "multiple partners" and "ongoing discussions" seems to becoming a running gag (not just for Cynata, but the industry in general), going out there and throwing around with names of companies we could be working with wouldn't exactly be a solution. What we need is signed deals (and I'm not talking about another contender for the title of World's Longest MoU...).