Based on the FDA's own guidance of timelines, we must be close...

Based on the FDA's own guidance of timelines, we must be close to hearing back from the FDA regarding their decision on how Mesoblast is to proceed with Rexlemestrocel-L for the treatment of CHF .... AA with Confirmatory Trial or go away and undertake an additional 3 year phase 3 trial ?




While some naysayers would have scoffed at my above post outlining the previous CHF Cephalon partnership deal / $$$ involved, they should perhaps take a look at some other biotech deals for indications far less advanced than Rexlemestrocel-L used in our DREAM-HF phase 3 trial that showed remarkable results for high-risk HFrEF patients with diabetes and/or myocardial ischemia ... for example;



https://www.fiercebiotech.com/biote...bb-pens-475m-dragonfly-pact-for-il-12-program
_{Bristol Myers Squibb pens $475M Dragonfly pact for IL-12 program}


This indication only just passed phase 1 trial in March 2022 so a far cry from the results Mesoblast received in our DREAM-HF phase 3 trial - just sayin'


https://www.prnewswire.com/news-rel...gram-with-bristol-myers-squibb-301493115.html
_{Dragonfly Therapeutics Announces Achievement of Phase 1 Clinical Development Milestone for IL-12 Investigational Immunotherapy Program with Bristol Myers Squibb}

Mar 01, 2022, 13:00 ET





OR





perhaps these naysayers should take a quick look at some of the licensing deals in 2021 for early stage indications years behind our blockbuster treatment for CHF ?


https://www.evaluate.com/vantage/articles/analysis-insights/licensing-deals-rack-2021

Licensing deals rack up in 2021







I welcome folks to read the following statistics and think about just how much would big pharma pay to be involved with this indication at either the AA application stage or the additional phase 3 trial stage ?


https://www.cdc.gov/heartdisease/facts.htm
Heart Disease Facts