Hi FolksIn many previous posts I alluded to the problems with...

Hi Folks

In many previous posts I alluded to the problems with companies dealing with the FDA. I have had several.

Sometimes it beyond anyone's capacity to anticipate or even understand what possible roadblocks and delays they could throw up. So many WTF moments.

One of my companies MSB has been through the wringer a number of times. I won't go through the details except that they have a treatment for children experiencing graft host Disease. This has an extremely high mortality rate with as yet no alternative treatment.

Here is a bit of todays announcement. It's not approval as yet, but just asking for re-submission.

THAT AVAILABLE CLINICAL DATA FROM PHASE 3 TRIAL APPEAR SUFFICIENT TO
SUPPORT BLA SUBMISSION FOR REMESTEMCEL-L IN CHILDREN WITH STEROIDREFRACTORY ACUTE GRAFT VERSUS HOST DISEASE (SR-aGVHD)

My purpose in todays post is to show you their long term charts look like as a bit of an eye opener of what can happen. Remember the vast majority of kids were suffering and dying from this with no alternative treatment available.

It was totally beyond my imagination to understand the the latest 4 year delay the FDA imposed and then finally reversed. That's only recent history look back over the decades.

On my chart you can't see the SP peak of 9.42 in 2011 then the fall to 96c in early 2020 followed by the rise to 5.30 in late 2020 and then the drop to 26c in 2024.

Now the question arises just how long will the delay be before the FDA approval of this new re-submission take and just how many more kids will suffer and die while this is happening.

Hopefully EBR totally bi-passes this experience. But with the FDA you can throw logic out the window.

Its the stuff of investors nightmares.

cheers Lies