Hi team MSB
Looks like the monoclonal antibody Gohibic, which targets inflammation in COVID ARDS, just got an EAU for hospitalised COVID patients. This is what we were trying to achieve for Rem-L.
I take some comfort in this decision (even though it seems right now monoclonal antibodies look like our biggest competitors):
1. The FDA still sees COVID as a global emergency. Tick.
2. Our next clinical trial with Vanderbelt is targeting all cause ARDS (i.e. not just COVID ARDS).
3. IMO Remestemcel-L has a much superior safety profile compared to monoclonals when targeting inflammation.
https://www.medscape.com/viewarticle/990441?ecd=wnl_recnlnew5_ous_230406_MSCPEDIT_&uac=457971MR&impID=5312528
Next I found this on Gohibic's Adverse Effects. IMO not so pretty (like Ruxolitinib's side effect profile for GVHD). Rem-L will most likely have a definite advantage in terms of safety if approved IMO.
https://reference.medscape.com/drug/gohibic-vilobelimab-4000305#4
and Warnings:
https://reference.medscape.com/drug/gohibic-vilobelimab-4000305#ANyAAN
Now fingers crossed for a positive (and hopefully early) GVHD decision; and equally as important a favourable CHF meeting with the words AA mentioned. Both likely IMO and not long to go
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