2024 Here we go again., page-603

I think I am pretty close with my original guess last year about CLBP being 26/27..... CHF has moved forward thanks to accelerated approval and will beat CLBP if approved.

Updated timelines:

Dec 24 -> Pediatric Actute GvHD Approval decision

2025 -> Pediatric sales for SraGvHD, Off label for adult SR GvHD

2025-> H1, Adult study srGvHD fully enrolled

2025 -> Jul to Dec 25 Accelerated approval reqest for CHF

Dec 2025 -> CLBP interim results

BIOREACTORS turned on around now
2025 H2 -> 2026 H1 -> Approval of accelerated CHF treatment and Major partnership announcement. $Multi Billion dollar market
( but extremely specialized )

2025 H2 -> Adult SrAGvHD interim results

2026 H1 -> Adult SRaGvHD Top line + resubmission

2026 H2 -> Chronic GvHD starts enrollment

2026 H2 -> Phase 3 CHF class 2 / 3 with elevated inflammation levels starts enrollment.

2026 H1 -> CLBP topline results

2026 Dec-> CLBP BLA

2027 H1 -> Adult SrGvHD approval $Billion dollar market

2027 H1 -> Chronic GvHD topline results + BLA

2027 June CLBP approval $Multi Billion dollar market

2028 H1 -> Chronic GvHD approval $Billion dollar market

2028 -> CHF Class 2 and 3 accelerated end point top line results

2029 -> CHF class 2 / 3 + inflammation approved.

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On the to do list

Crohns

Sepsis

ARDS

Inflammatory disorders



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