Ann: Mesoblast to File BLA for Ryoncil FDA Approval Next Week, page-137

I know we have not quite done this topic to death, which can easily provide an opportunity for stock manipulation, so here it is:

Sectiom 901 of FDASIA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow the FDA to base accelerated approval for drugs for serious conditions that fill an unmet medical need on whether the drug has an effect on a surrogate or an intermediate .clinical endpoint.

In this case, GI bleeding is a meaningful surrogate.

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval#:~:text=Section%20901%20of%20FDASIA%20amends,or%20an%20intermediate%20clinical%20endpoint.