At least you finally stopped the charade with your "interesting" points to discuss and made it clear that the only thing that brings you here is taking pleasure when the CYP SP is going down. The only person chasing anything over here is you - new personal lows. Well done, watch you go!
As to the SP decline, I was about to post the same as
@bedger for the ones that are not aware that MSB was trading at $9.32 in October 2011. Sure, pick the timeframe that suits your lows the most, but anyone capable of using Google won't have an issue to see through it.
Thank your superiority remarks in regards to Marks. Clearly you have not read any of the correspondence leading up to CRL#1 and CRL#2:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/ryoncilThere is no need to demonstrate superiority, hence you didn't have to (try again):
I'd say re-read the publications, but I doubt you have read it even once. A lot of the points mentioned by
@JB1975 are also covered (albeit heavily redacted), exactly the way he/she predicted it at the time prior to CRL#2.
Coming back to your statement that CYP can stop the trial in aGvHD now that Ryoncil is approved, and repeated (rephrased) after the Orphan Drug Designation announcement.
I know, for someone that even gets the food pre-chewed, it is probably a big ask to draw your own conclusions, but this is addressed to the ones that can:
1. Why does the FDA mention that Ryoncil is a "allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy," when it is claimed to cover all MSC therapies?
2. Why does the FDA mention SR-aGvHD, when it is claimed to cover aGvHD?
3. Why does the FDA mention "in pediatric patients 2 months of age and older," when it is claimed that it covers adults as well?
All quotes are from the official FDA press release found here:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-hostMay I suggest to also read the official FDA review in the lead-up to CRL#1:
Yeah, I know you won't. Not enough pictures and not talking about Ireland, hence not of interest.
Ssomeone familiar with the above would and should quickly point out that this is a comparison with the previous manufacturing process - and you would be correct, it is. To which I would reply to show me the new data that MSB talked about they will get in adults. Years ago they talked about a trial in adults already in planning stage. It is now 2025.
Back to my remarks 1-3:
"one can conclude thatremestemcel – L is not effective when used as an add-on therapy for the treatment of newlydiagnosed or SR-aGVHD. The lack of superiority of combination regimens over singlepotent immunosuppressive drugs for treatment of SR-aGVHD is well-established in theliterature, and the observed outcomes of these trials is not unexpected."
So, you said Cynata may as well stop the trial, in newly diagnosed adults with HR-aGvHD:
https://clinicaltrials.gov/study/NCT05643638?term=cynata&city=&checkSpell=false&rank=1Cynata is targeting exactly that group that has historically shown to not respond well if used as an add-on therapy with SOC immunosuppressants. Based on that, there's a good chance it won't.
But what if it does? Could that make it SOC? How would that impact a therapy targeting a patient pool that does not respond the SOC? Could that impede the potential number of patients if you can get a CR before SR onset?
We will find out soon enough if it has the potential.
What to discuss next, patents yet again or another topic that brings you so much joy and makes you get out the lotion and tissues - running P1 trials in Australia.
Yes, Cynata ran 3 P1 trials (including MEND) in AU and not the US - so what?
You want to compare because CYP is not a thread, then don't use an acquired P3 product, but instead your "own" platform.
Did you know (trick question, of course you don't) that the underlying technology is from South Australia?
https://www.aim.com.au/blog/silviu-itescus-hard-cellThe first P1 trials were conducted in AU in 2004?
Bone fractures and refractory angina:
https://www.aspecthuntley.com.au/asxdata/20051207/pdf/00574500.pdfDue to the established safety profile, MSB could skip the P2 trial in the US.
21 years later, do you have any approved products of your MPC platform in the US?
Cynata was listed on the ASX in 2013 and is developing its licensed iPSC-MSC platform, from scratch and so far being the only iPSC-MSC platform with completed P1 trials, an ongoing P2 trial, and a fully enrolled P3 trial. I think we are on track, even if you keep pumping and drumming your chest like Donkey Kong about your 2013 acquired MSC platform that had at that time already completed more than 1 P3 trial. But this is where you do your usual trick again, post a different timeframe to suit your agenda or deflect in any other way.
You have nothing of interest to offer, neither here nor over there at your playground. Sad thing is, you know that already, but seeing CYP's SP getting lower is the only thing that makes a miserable existence somewhat bearable.
Enough for one day.
(20min delay)