A bit rich I must say. Your first time on this thread as you say, yet very quick in judging "even thr people who are bullish on this stock."
Given that your first paragraph straight away mentions "not interesting enough [...] to put any money into it just yet", why don't you share with us your research on the science and the pathways to show what your view is based on. Whi knows, it may even spark an interesting conversation.
I read something of your posts on MSB.
Yes, MSB is still due to pay royalties to Osiris until the tenth annoversary of the first approved MSC treatment (Japan, 2016).
Off-label use is in the physicians discretion l, which generally also invludes taking into account clinical evidence in that particular indication - check out the results of Osiris Protocol 260, something you will naturally come across if you look at why MSB pursuit such a small indication as SR-aGvHD and then decided to only trial it in a very small subpopulation again (children), when at the time the pathway to adults was also still open:
https://www.fiercebiotech.com/biotech/osiris-therapeutics-announces-preliminary-results-for-prochymal-phase-iii-gvhd-trialsYes, we have heard that the product has improved since then, but back to the physician prescribing it. "I have a product that has been approved in children after failing to get approval twice before. The product has been approved, but the only data I have in adults from 2009 is showing no statistical difference compared with placebo. Since it is off-label use, you have to check with your insurer if they cover the cost."
We will see how the market adopts. At the same time, this is the chance for Cynata and the pathway you have been exploring. There IS clinical MSC evidence to compare against and there is also now a product with massive side effects currently being used due to a lack of alternatives. Then there is Marks, who seems to have developed his version of the japanese SAKIGAKE pathway, but at the FDA.
Of course, still many ifs and buts (including complete recruitment and more so, showing that the results are superior to current treatments in adults with high risk aGvHD) along the way, but the way may be shorter than what you think.
Granted,
https://ashpublications.org/ashclinicalnews/news/2973/FDA-Emphasizes-Need-for-Phase-III-Clinical-Trials. However, under Marks we have seen what many didn't expect. Now if you have the target population, the dosage, a direct result comparison against a blinded placebo group and you can show that the therapy works and comes without the side effects of a product currently being used - is there a chance under Marks?
https://www.biospace.com/asgct2024-fda-s-marks-on-accelerated-approval-gene-therapy-costs-and-more
(20min delay)