Thank you
@otherperspective for a researched post. I always appreciate someone challenging my views, especially if it is done backed up with links, allowing me to do my own reading. I also value your posts on the MSB threads. I much rather respond to a backed-up opinion, as opposed to posts, where there the mere objective is to throw dirt and to deflect.
In your post, you said the following:
"JCR do not make it clear the reasons for the projected shortfall in Mesoblast royalties for the next quarter. Indeed the only information posted on the JCR forward annual plan reports a decline in the next 12 months sales. For this reason you probably concluded that this was a negative development. However, you would be wrong. Ignoring for a minute that Bell Potter have already reported that demand is running substantially ahead of supply...reportedly by 1.8 times ...which is evident from the growth shown in the previous 12 months audited royalites ..you miraculously forget to take into account the supplementary agreements (plural) signed between Mesoblast and JCR to extend the licence agreement into other areas such as Hypoxic Ischemic Encephalopathy (HIE)"
The points you raised made sense at first, especially since I couldn't find anything stating otherwise. I also thought that perhaps COVID-19 contributed to and isse down the production/manufacturing line.
Last night however I finally came across an official document on a Japanese website (Google translate makes things a bit easier these days):
https://www.jshct.com/uploads/files/news/20200409.pdf
I had to use Google translate (except one sentence, which I had to get checked to make sure I get a correct translation):
"TEMCELL® HS Inj." Apology and request regarding supply of
Thank you for your continued support.
We would like to thank you for your continued support of our products.
It has been four years since the launch of Temcel® HS Note, and we have received a prescription that greatly exceeded our initial expectations.
I am. Our production department is also making every possible effort to increase production, including equipment expansion.
However, this time, when we inspected the test sample for the latest shipping product,
It was found that the shipping criteria were not met.
- this is the Google translate version.
Our company's product division are trying to increase production including infrastructure but on this occasion of testing the sample, which was going to be delivered, it did not meet the standard.
- this is the checked translation
As a result, we cannot secure enough dose for new patients after April 13, so it is very painful.
We would like to inform you, but until the supply system is ready, we are currently receiving Temcel® HS injection.
We would like to offer it only to the person. Regarding the timing of resuming supply,
We would like to contact you.
We apologize for the inconvenience caused to all medical personnel and patients.
We sincerely apologize for the inconvenience and thank you for your understanding and understanding.
Thank you for your cooperation.
I think that makes it pretty clear that a trial, intended to treat 12 patients, which started enrollment in September last year, plus the 200 odd patients treated in GvHD, is not responsible for the stop of treating new patients in Japan.
I mentioned in my previous post, that PMDA came across it back in their "Report of Deliberation Results" for JCR's TEMCELL (dated 2nd September 2015):
The PMDA was then satisfied with the measures put in place to control the risk associated with variations:
https://www.pmda.go.jp/files/000215658.pdf
Despite all the talk about it not being a thing, it was in 2015 and it still is in 2020 in Japan.
Given that there is now so much interest in memes and other pictures on the other thread, especially when it comes to posters that dare to have a contrary opinion (mostly from the newbies that managed to grabbed shares at a bargain price due to COVID-19), I thought I might as well give it a go (or three):
Having said that, being first to market - as proven in Japan - will make a huge difference. And I have no doubt, that MSB will eventually overcome these issues. It will however still require further testing if you make changes to the existing product, given that you even have to do further testing if you change your CMO. SI has proven over many years that he can build a multi billion dollar company from scratch and despite having to overcome multiple placements, loans etc, he managed to keep the big boys interested.
Whether or not the manufacturing issues will be achieved using dental pulp MSCs, 3D bio reactors - time will tell.
I just hope I'm not infringing any MSB patents by chewing my food using my own teeth...
Regarding that, I do believe that MSB has valuable iPSC patents. Just check the 2018 Cartherics deal CAR-T deal:
https://www.asx.com.au/asxpdf/20180529/pdf/43vcrvpgkyqvyy.pdf
Bottom line:
There is more than one car manufacturer.
There is more than one TV manufacturer.
There is more than one mobile phone manufacturer.
etc.
Happy to pick up on this topic again later on.
(20min delay)