IMO the significant magnitude of the therapeutic effect for...

IMO the significant magnitude of the therapeutic effect for participants meeting response markers thresholds seen with Rem-L (aGvHD - MAP score via two biomarkers --- overall survival) and RexL (CHF - CRP biomarker and/or diabetics/ishemics/LVAD --- decrease MACE) will play an important role in awarding an Accelerated Approval (or unconditional approval).

Also the unmet medical need (Rem-L for paediatrics 12 years and under for aGvHD; and Rex-L as a therapy to halt/slow CHF disease progression via a mechanism other than targeting fluid overload - i.e. targeting inflammation). Also there seems to be no adverse interactions when used on top of SOC and in general demonstrating an excellent safety profile.

Makes a strong case for Accelerated Approval for predefined groups IMO (for both Rem-L and Rex-L). Favourable Benefit to Risk ratio IMO.

Also be aware that the FDA has no jurisdiction to advise on prices to be set my MSB for Rem-L and Rex-L and therefore a cost-effectiveness analysis will not be conducted by the FDA and therefore will not influence their approval decisions. So no risk here. This is a job for the payors (primarily medical insurance companies in the US) and correct me if I am wrong but from memory SI indicated he already has reimbursement deals in place with some major insurers in the US.

The biggest risk of a full rejection IMO is if FDA do not approve potency assays - but from memory SI has more recently announced we have addressed these issues - and has been in active dialogue with FDA. So in short, IMO there is a good chance we may have positive news this year for both Rem-L and Rex-L.

Good luck holders