"Is it because it is a donor-matched therapy, not quite the...

"Is it because it is a donor-matched therapy, not quite the same as our off-the-shelf allogeneic therapy?"

Hi LED, I think from your previous comments/question (shown above) that you may have come to the conclusion that Omisirge it is a donor-matched therapy (and therefore not a true off-the-shelf allogeneic therapy) based on the wording in the announcement you found below: "Each dose is patient-specific, containing healthy stem cells from an allogeneic pre-screened donor".



To give you insight on how I interpreted the same paragraph:

* I do not draw the same conclusion that it is a donor-matched therapy from the phrase "each dose is patient-specific". Instead I interpret this phrase quite literally as it reads "the dose is patent-specific". In other words, my opinion is that it is a 'true' allogeneic off-the-shelf therapy (not donor-matched) with the caveat that the dose may differ between different patients (i.e. maybe the dose is based on body weight etc).

* In addition the article states it is an allogenic (off-the-shelf) cell therapy: "containing healthy stem cells from an allogeneic pre-screened donor". If the therapy required donor matching then they should not be able to flaunt that it is an allogenic ready to go cell therapy? Most likely their wording (or lack of wording) in the announcement makes its interpretation on this point somewhat difficult/ambiguous.

In short, IMO Omisirge (like Ryoncil) is a true off-the-shelf cell therapy (ready to go). In my mind its just that Omisirge may give each patient (approved for 12 years and older) a different dose likely based on factors like body weight etc (but the product is based off that same 'pre-screened donor').

That's how I interpret this article anyway. Don't get me wrong, if I interpreted the article the same way you did (i.e. product was donor-matched) then I would also agree that it is different from Ryoncil and therefore not a 'true' allogeneic (off-the-shelf) ready to go therapy.

But wait, there's more, your view made me do a little more digging and I found:


Now based on this article/passage it may be interpreted like this is not a 'true' ready to go 'off-the-shelf' product. I mean 30 days to reach transplant centres after the start of manufacturing. Why the large time lag? Is it due to manufacturing capacity or gearing up for product launch? Are they making each product from matched donors like you suggest which is different from Ryoncill and therefore not a truly off-the-shelf product? Again, some confusion. Now I am doing my head in, enough for now.

Either way, I don't see Omisirge as a true competitor so I can rest easy and count down the limited days to the potential Ryoncil approval (and potential bombshell news of an AA or major partnership deal on the CHF front).

Appreciate all your posts. Good luck with your Options and Have a great day.