"is this not the CYP thread" - cute...
https://hotcopper.com.au/threads/bell-potter-conference-up-dates.8027466/page-227?post_id=74150132This appears to be the MSB thread, yet you are talking about what exactly?
Then you share your usual bating posts here and MSB is off topic in your opinion - if you want to play judge, start with your own posts. As I said, I'm happy to play ball.
Coming to the points you made.
Of course JCR would have to pay MSB a license fee, given that their MSC technology dates back to a partnership with Osiris from 2003, which MSB took over as part of the asset sale:
"In August 2003, we entered into a license agreement with JCR Pharmaceuticals Co., Ltd., pursuant to which we granted to JCR an exclusive right in Japan to our MSC technology for use in connection with the use of hematopoietic stem cells derived from peripheral blood, cord blood or bone marrow in the treatment of hematological malignancies."
https://www.sec.gov/Archives/edgar/data/1360886/000104746913002788/a2213414z10-k.htmWhen someone's technology has its foundation on existing Osiris patents due to a partnership agreement, wouldn't you consider that any additional indication using that said technology should also be covered under that?!
"Takeda paid more to move to move into the US market" - for Takeda, these amounts I dare say are chump change. Again, to them a delay is also more costly than paying said fee. Just look at the numbers attached to the agreement between TiGenix and Takeda from 2016 and you know where you are at. If the patents are so fundamental for Takeda to enter in the US market, should the royalty payments be more reflective of the original licensing agreement between TiGenix and Takeda?
You give me that Cynata tried to enrol Grade 4 patients - how kind of you. They couldn't enrol Grade 4 patients, that's what all papers and study reports say, correct. But they were open to it. Was MSB open to enrol adults? Open to enrol other patients whose expected clinical result weren't welcome in a trial to meet primary endpoints if you use acquired historical data?
You are right, the reason for a trial in children is obvious - different reasons for you than other non-holding observers though. You were talking about saving lives, not only children lives, weren't you? The conclusion reached after data mining surely was simply due to children not being allowed in other trials...
Are you saying the FDA put a clinical hold on all MSB trials post CRL#1? Do you have a source for that?
https://www.copyright link/companies/healthcare-and-fitness/mesoblast-says-fda-has-not-put-a-hold-on-drug-trial-20210901-p58nqpI have no idea what Cynata's quantity measures are as I have not come across it yet in the public domain. What we do know, is Cynata's MoA view - see Kelly et al:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8577186/I agree, an FDA accepted potency assay will be very valuable, just like the comments made during ODAC as that was the first time the FDA had to decide on an MSC product. Given that the trial in the US was on the agenda anyway, the accepted potency assay comparison would have not been on their minds at the time. And at this stage, there is still no approved MSC product with an FDA accepted potency assay.
I said it many times before and I am happy to say it again, I hope MSB will now finally gain approval if all FDA requirements are met, the cells can help the patients that need it the most and in whom it has shown to make a significant difference (Grade 3/4 / C/D), with insurance companies willing to reimburse the treatment. The last thing these patients/parents of these patients need is in addition to a severe illness of a loved one, mortgaging their homes to buy a lottery ticket for a treatment that may or may not work as intended. Banking on simply off-label use may not be the best bet here going forward.
Don't keep telling us to be happy about MSB here, MSB there (see potency assay, see first approved MSC product in the US a while back, see your comment to JB above) etc. when trying to talk everything and anything "Cynata" down, simply because it is a stock that is also using MSCs and is developing products in an area where it could compete against MSB.
Time to put the biased opinions aside for a while and hope for good news to come for both companies over the coming months.
I hope you and your FB group filled up your cups, pots and pans with shares when it was in the 20s, 30s and 40s. If so, well done. And I sincerely hope that there is more to come - for all of us.
(20min delay)