Hi LEDResponding you your question: "Is it because it is a...

Hi LED

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

It is my understanding Gamida is a true allogeneic therapy (not so sure about your statement it is a donor-matched therapy). My understanding is that Gamida is used for patients who are unable to find a matched donor in a timely manner (i.e. it is not a therapy that is matched to the patient; instead it is an alternative allogeneic cell therapy given to a patient where a readily available match does not exist - a true allogenic 'off the shelf option). This therapy will mainly benefit African American patients who find it harder to find a match on the donor registry.

Now for my 2 cents:

Firstly, the FDA have now approved an allogeneic cell therapy (i.e. one barrier has been removed for Ryoncil).

Secondly, Gamida is not a competitor (it is not used to treat GvHD; instead it shortens the time to neutrophil recovery, which equates with reducing bacterial and fungal infections). If anything it may increase access to stem cell transplants, from which GvHD may be a complication of such potentially life saving treatment.



Also regarding Gamida is not a competitor, their safety is similar to the suspected adverse events following the necessary stem cell transplants which Ryoncil treats. In other words Gamida is not a product that has been shown to reduce the incidence of GvHD and therefore is not a competitor to our product Ryoncil.



https://www.businesswire.com/news/home/20230417005809/en/Gamida-Cell%E2%80%99s-Allogeneic-Cell-Therapy-Omisirge%C2%AE-omidubicel-onlv-Receives-FDA-Approval

IMO - positive news for MSB. IMO - Ryoncil will receive significant more news coverage if approved because it is a cell therapy that has been shown to save lives in patients 12 years and younger who are unfortunate to develop aGvHD as a potentially fatal complication of the needed stem cell transplant (where there is no other approved alternative after steroids have failed).