Time zones...
"The FDA is in favor of consistent manufacturing platforms".... Thank you for the obvious. Of course, but it doesn't mean that safety and efficacy can be sacrificed at the altar of consistency.
"iPSC's are by nature the right cells to achieve this (ie consistent manufacture)". Really? Your own poster, Mr Pfeifer, tells us some of the concerns in the threads that follow your post. One of them being that some cells may lag in differentiation retaining their "pluripotency", which would include the potential to form or promote tumors. The quote he provides from SI is a thumbnail sketch of the main difference in philosophy between the two approaches, MSB vs CYP:
Bingo. To each his own. You prefer CYP, I prefer the MSB approach... like pitted prunes one can never be sure one has removed each and every "pit" (iPSC) from a large batch, and it only takes one to break a tooth. Here, trillions of cells are involved... and it may only take one that remains primitive and undifferentiated to lead to an unanticipated effect, maybe months to years down the road. A lot of safety work in front of CYP - and that's going to mean long-term observation of phase 3 participants, imo, or at least phase 4's, given FDA sensitivity after getting burnt on cancer side effects by other products.
Regarding patents, yes, CYP no doubt has many patents... and MSB has many patents, including the foundational patents on MSC manufacture obtained from Osiris. Issues of infringement will be resolved at a level higher than this MB. Regarding the specific patent you cite, it looks narrow. As a competitor I would try expanding cells with the excluded PDGF or some other growth factor like VEGF. Meanwhile, MSB is not going the iPSC route, so not clear it is germane to this board.
Regarding dosing, best to reference official documents such as can be found at clinicaltrials.gov, as opposed to the ramblings of a soccer fan. That also avoids non-standard unscientific abbreviations like mio*, whatever that means. The dose being used by MSB in the phase 3 C-19 ARDS trial is 2x10^6 cells/kg. Repeat once if needed. Administered by slow IV infusion. That is not an unusual dose based on a myriad of studies that have been done using MSC's. It also happens to equal the high-dose arm of CYP's phase 1 dose-finding study, so not clear where "CYP using 1/12 the dose" is coming from? What is the (proposed) dose being used by CYP in C-19?
Regarding timelines, my original post was based on "date company was founded", not the date company went public or got acquired... If you feel more comfortable saying 9 years difference, fine. Point conceded. I won't concede that Mesoblast is a hard act to follow - never said it couldn't be overtaken, but that will take time, while Mesoblast continues to advance. I also stand by my statement that the regulatory process for stem cells is now more clearly defined at the FDA than it was 7 or 8 years ago - which makes the regulatory climate "easier" for potential competitors. One of the reasons Osiris sold to Mesoblast was that it continually hit a brick wall with the FDA, which really didn't have the expertise in place to fully evaluate stem cells. Osiris sold in 2013 and things were already starting to transform at the FDA, as one may see from this piece dated 2104:
https://www.fda.gov/consumers/consumer-updates/adult-stem-cell-research-shows-promiseSo, the FDA set up its own dedicated laboratory specifically to study MSC's. And they brought in experts to help evaluate clinical trial designs and manufacturing processes. That was followed by the passage of the 21st Century Cures Act in 2016 that created the RMAT designation for therapies based on regenerative medicine. That was followed by a complete overhaul of the HCT/P regulations governing cell products in 2017. So, the regulatory process is much clearer today than it was for companies just 7 or 8 years ago, and that's a good thing... but it also emphasizes the hurdles Mesoblast had to cross to get where it is. So, a hard act to follow but no one is saying it's an impossible act to follow.
You've accomplished your mission.
(20min delay)