https://youtu.be/qm9uQGHs0y4VIDEO link with Dr Perin...

https://youtu.be/qm9uQGHs0y4
VIDEO link with Dr Perin speaking.

EARLIER I POSTED THIS WITH WRONG MINUTES.

Please listen to this video from minute 57 to 59.

Here Dr Perin talks about Mesoblast’s CHF treatment.

Seems that Meso is gearing up for a confirmatory CHF trial.

Mesoblast shall partner up (my best guess is Astra Zeneca). I think an announcement soon.

In my opinion, this is the best time to buy.

You are looking at a company which shall be a minimum Disallowed in the next 12-months.

Not investment advise, however my opinion only:

There is a huge unmet need for Diabetics and Ischemic’s with Inflammatory biomarkers in the CHF Indication. I shall later refer to this subset as “high risk patients”.

You might question if it’s even ethical to run another trial given the overwhelming efficacy for these patients in the last multi-center phase 3 trial.

The company received feedback from the FDA to focus on the patients at highest risk for death or other major adverse cardiac events (MACE). Consequently, the upcoming meeting with the FDA under the existing Regenerative Medicine Advanced Therapy (RMAT) designation shall discuss the potential marketing approval pathway for rexlemestrocel-L in high-risk patients with HFrEF (Heart failure with reduced ejection fraction) and recorded inflammation.

Diabetics are the focus in my opinion for the upcoming Accelerated Approval (AA) and thankfully Mesoblast has a multi center Phase 3 completed because this meets FDA guidelines for the AA.

Confirmatory trial with surrogate endpoints would take 2-years instead of 5-years.

I have loaded up with options on MESO, 2.5$ calls for Jan 2025 and Jan 2026.

As well there is also a possibility for an approval next year for the aGVHD pediatric indication, however Heart (CHF) is a blockbuster indication worth over twenty billion USD to the company.