Ann: Appendix 3G, page-57

@Barman76

"re "comparing the incomparable" comment, any conclusion drawn from MSB improved P3 to CYP P1 is "comparing the incomparable", lets not change the facts of the discussion had. You cant compare these. one is adults, one is for children. MSB had sicker people in its cohorts. unless you want to compare to a product not progressed. That's not the product going to be approved/sold. Whats the point/relevance?"

That was the discussion at the time as the TEMCELL product was co-developed with Osiris, which still appears to be used now, HOWEVER improvements have been made after about 2/3 of the patients receiving treatment in Protocol 275, the trial preceeding the single-arm study.
I have seen the slides and was impressed. Maybe we are talking about different products, maybe. I suppose a second trial in adults as suggested by a MSB representative currently in planning stage may answer this question. Until then, would you call it a fact? If your answer is yes, would your answer be the same if CYP had made that statement?


"3D...... you both demanded a link, you both said it wasn't within MSB capability, link was provided, you all went quiet. more information has subsequently been published much to my delight, every time. You only remember the convenient parts to your story, you've clearly re-written it in you memory. which reminds me of the: "one bone marrow harvest yields 1000's of treatments" stated by MSB. Which you both claimed otherwise, until a link was given. More information has come out since. My reply to any claim from you both or anyone about manufacturing of either MSB or CYP has always been, rebutted by myself "not enough information is in the public domain to claim either way". that's a polite way of saying, "anyone claiming to know, is lying". You cant deny me that one, yet the claims stated are pumping at best."

You keep switching between doses and treatments. The way I read it, they use the term "treatment" to describe the whole process, including multiple doses per infusion, with 8 infusions during the initial treatment and potentially another 4 infusions as a follow-up.
A MSB representative now mentioned that a single donor can provide enough cells to treat about 400 patients (being very sick children).
In the case of GvHD, which is what we have always referred to when talking about it (as that is the only CYP product that has been tested during a clinical trial), your statement is incorrect.
HOWEVER, given that the trial for COVID-19 ARDS only uses 2 infusions at 2 x 10^6 cells per kg bodyweight, I am happy to acknowledge that in this indication using remestemcel-L you are likely able to treat (400 patients x 8/2 infusions / 2 as double the weight) close to 1,000 patients. Perhaps MSB needs to be more specific as to what a patient is and which indication they are referring to.


"3D...... you both demanded a link, you both said it wasn't within MSB capability, link was provided, you all went quiet. more information has subsequently been published much to my delight, every time. You only remember the convenient parts to your story, you've clearly re-written it in you memory. which reminds me of the: "one bone marrow harvest yields 1000's of treatments" stated by MSB. Which you both claimed otherwise, until a link was given. More information has come out since. My reply to any claim from you both or anyone about manufacturing of either MSB or CYP has always been, rebutted by myself "not enough information is in the public domain to claim either way". that's a polite way of saying, "anyone claiming to know, is lying". You cant deny me that one, yet the claims stated are pumping at best."

I'm pretty sure I didn't say it wasn't within MSB capability. What I am saying is, they are working on it. Yet you treat it as proven technology and therefore a fact when at the same time you say Cymerus is not a proven technology as it has only been applied to 15 patients in a clinical trial.
In how many patients has MSB applied the 3D technology to date?


"COGS.... will it be a material difference? id say again "not enough information is in the public domain to claim either way". You claim there is, its the basis of your investment. I say again i haven't seen proof of that as "not enough information is in the public domain to claim either way"

Now you say now enough information in the public domain. It sounded different before:
"with the the advancement of our 3D and limited costs of media I think the real difference isn’t worth it."
Again, if a poster on the CYP thread makes a statement and adds "I think", it is considered ramping. However, such statement seems to be perfectly fine on the MSB thread.


Shut down comments have happened at both sides for years. Like you, I'm sure I had my fair share as well. Although I have "come around" recently and am not afraid to admit that I have a lot of respect for SI and his work, I have made the decision and stand by it that I won't be investing in MSB for various reasons - even when I could see that the adcom was going to vote in MSB's favour (no brainer!).
I believe in the Cymerus technology, did a lot of reading and came to the conclusion that - although still a bit ahead of its time - we should see increasing demand in this sector (also thanks to MSB), which may cause many big pharma companies to reconsider their approach. Given our extensive pre-clinical data (with new additions to be added soon), it should make this technology very lucrative alternative - IF we can produce further compelling data in other clinical trials. Likely not for companies that have set-up their own platforms like MSB, but newcomers and companies already familiar with the iPSC space in general and MSCs in particular.