That may be so, interesting though that after filing in July 2018, the "main request filed on 11 November 2019 and the description filed during the oral proceedings on 13 January 2020." I like the EPO articles cited as it seems to go into the Mayo/Prometheus direction and also find the paper titles cited by the opposition very interesting as it appears that MSC research in various indications that HC patent experts claim MSB-ownership and exclusivity appear to have taken place "B.M." (Before Mesoblast).
Of course you can suggest a newer version in place could be stronger - you are free to suggest as much as you like and as often as you like. May I suggest, instead of the usual baiting posts, back up the "smoking gun" you believe to have found with links/sources and in this case, specify where you see a patent being being infringed exactly, as that would would allow for a discussion that we couldpotentially all benefit from. Whilst in the end neither of us will finish such such discussion with a law degree, it may help us making a (better) informed financial decision.
"the patent would also have Oaktree on it" - it sure does... Security on a loan that some seem convinced does not attract any interest charges.
I never said it was valueless.
"What were these guys thinking?" Are we diving into these sorts of reasoning again? I'm having a few déjà vu's here: "Novartis - what were they thinking", "SurgeCenter bought in at $2.30 - what were they thinking." The latest one I think is GG - what is he thinking. Over here it was (myself included), "FujiFilm - what were they thinking." Haven't we all grown out of this childish way of justifying our investment decisions?
What happens if our cells work in OA? Who "will be a little bit interest with $$$ in sight?" Your "crew"? As I mentioned a few years ago, please get your "crew" to contact my "crew" and we will see what happens. Until then, again, since you are so convinced of patent infringements, please specify exactly which patent do you see infringed and why?
Cryopreservation? Isn't there a decision from 2012 referencing the following:
http://cafc.uscourts.gov/sites/default/files/opinions-orders/10-1547.pdfTeva Pharm... funny that. Another déjà vu comes to heart I mean mind, "what were they thinking." So obviousness, non-obviousness is a tricky thing. Remember the links/papers I mentioned before cited by the opposition Rainer Friedrich?
December 2003, "Immunomodulatory effects of fetal and adult mesenchymal stem cells" - author, Le Blank, K. Wasn't she the first one to report treating servere aGvHD in a 9-year-old in early 2000, B.M.?
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)16104-7/abstractMore details can also be found here:
https://ki.se/en/research/groups/mesenchymal-stem-cells-katarina-le-blanc-groupAnd wasn't the first trial ever using MPCs reported in 1995 by Caplan?
https://scholar.google.com/scholar_lookup?&title=Ex%20vivo%20expansion%20and%20subsequent%20infusion%20of%20human%20bone%20marrow-derived%20stromal%20progenitor%20cells%20%28mesenchymal%20progenitor%20cells%29%3A%20implications%20for%20therapeutic%20use&journal=Bone%20Marrow%20Transpl&volume=16&issue=4&pages=557-564&publication_year=1995&author=Lazarus%2CHM&author=Haynesworth%2CSE&author=Gerson%2CSL&author=Rosenthal%2CNS&author=Caplan%2CAIWhat makes MSB's approach different to the "prior art" applied at the time? Is there a difference? And if there is a difference, couldn't there be another different approach being applied by Cynata?
I did bring up Tigenix and Takeda, correct. Takeda waited for this to be resolved before pulling the trigger. "some very handy $$$ for MSB" - fortunately "up to US$24 million" that weren't received in the form of a CR of and/or resulted in a SH dilution. Where are we up to now? US$1 billion? I lost count...
But lets look at the bigger picture here - the TiGenix Takeda transactions was already in the wings, with a US$627 all-cash deal ready. An upfront payment of US$6 million to potentially delay an all-cash deal of US$627 million. Put that money in the bank for a year at that time, how much interest would you have earned? More than 1%? Did TiGenix management witness the next payment of US$6 million due within 12 months of signing the agreement?
Yeah, not the best example here if you are trying to make a point as to why there was no challenge and instead a payment of US$6 million agreed and made by TiGenix management.
https://www.aspecthuntley.com.au/asxdata/20171215/pdf/01934406.pdfhttps://www.fiercebiotech.com/biotech/takeda-strikes-eu520m-deal-to-buy-cell-therapy-firm-tigenix#:~:text=Takeda%20has%20put%20together%20a,European%20approval%20in%20Crohn's%20disease.With that in mind, I am pretty comfortable quoting Claudia Jimenez's statement
TiGenix's senior director of investor relations and corporate communications at the time again, thatTigenix “did not need the IP from Mesoblast to launch.” She said Tigenix licensed the IP to “add an extra layer of protection.”“We just wanted to be absolutely certain in the future that we would not encounter a problem,” she said, noting that Cx601 is protected not by the Mesoblast patent but by Tigenix’s own composition-of-matter patents.“It’s very fine wording,” she said, stressing that the patents “are important but not needed to launch. We wanted to avoid any future disputes or conflicts with Mesoblast in the future.”
https://www.bioworld.com/topics/84-bioworld
Interesting that in MSB's press releases you accept the "correctness" and "completeness" of what he says as it is all checked and reviewed by lawyers - or so I read. Yet the above statement, that must have somehow slipped through because they don't use lawyers in Belgium and/or Spain? Maybe we should send some HC posters over there.
Moving on.
Correct, there are no grade 4s. Did Cynata opt to not enrol them? No.
https://clinicaltrials.gov/study/NCT02923375?term=cynata&city=&rank=4
"Anything to safe a life" 1-2
Did Cynata opt to only enrol children? No.
Did Cynata opt to limit enrolement of other combinations or grades, such as "Grade C or D aGVHD involving the skin, liver, and/or GI tract or may have Grade B aGVHD involving the liver and/or GI tract, with or without concomitant skin disease?"
https://clinicaltrials.gov/study/NCT02336230
May sound familiar and the reason for that is an upfront payment of US$50 million and possible milestones (remember I brought it up during COVID)?
https://www.fiercebiotech.com/partnering/osiris-exits-stem-cell-business-sells-unit-to-mesoblast-100m-deal
That's not something the heart surgeon waiting for his coffee and donuts said by the way, instead a presumption made by Jacques Galipeau, "Gut and liver GvHD are more responsive than skin GvHD. In the absence of robust predictive biomarkers, these observations provide guidance in clinical trial design biased towards subject selection likely to be responders. These data likely informed an adaptive clinical trial design for NCT02336230 [...]."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434696/
In the absence of our forming CEO calling up his uni friends to pump more money into CYP (I doubt he could have even if he wanted to), Cynata was willing to enrol any adult patient presenting with SR aGvHD Grade II-IV.
Remember, the first investigator led clinical study in Japan in 2013 by Takahashi was halted due to safety concerns (resumed in 2016 and first patient enrolled shortly before Cynata), yet you are saying that regulators in Australia and the UK were willing to enrol patients to a trial that would have had the same chances for survival had they received a glass of water instead of CYP-001?
https://bioinformant.com/induced-pluripotent-stem-cell-ipsc-market-accelerated-by-landmark-events/"Anything to save a life " 2-2
Why not run another randomised trial in adults?
Instead, why only focussing on an "on ethical grounds single arm" shortcut via children with label extension to adults?
Galipeau citing a Kurtzberg trial:
"Subset analysis suggested that children with GvHD were responsive to MSCs(Kurtzberg et al., 2010)."
"In GvHD, it has been observed that children respond better to allogeneic MSCs than do adults overall(Kurtzberg et al., 2010)."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434696/
After CRL#1 (or #2) - why not run a trial in adults then, rather than blaming the heartless FDA and their outdated rules?
Had you run a trial in adults after CRL#1, wouldn't there be a possibility that Prochymal/remestemcel-L/Ryoncil could already save more lives in the US than just the ones lucky enough getting into your EAP?
But as always in your biased analysis, your "crew" is not at fault, EVER.
If you were told that your "crew" walked from Australia to the US for an FDA meeting, your only question would be how long it took them. Rumour has it that your crew touched a glass of water during the last conference call and it turned into wine.
"Fluff charts" - whilst I partly agree and wish that the last nature article had more details, fluff charts, well, I think @JB1975 pointed out a few Michelangelos amongst your "crew", in a way, that even I could follow for the greater part the dots he connected. All 11 of them. Although the last few posts I did misread as I lost interest after the usual "mine-is-better-than-yours" debate flaming up again. Because that's all it is. And that's why you are here. That's what you want to discuss over here when you start your usual "bating" posts. Now you have the opportunity. Serve us your best wine and lets talk (although if you don't mind, see if your "crew" could turn it back into water, carbonated, if that's not too much to ask for).
(20min delay)