Amylyx class action Relyvrio, page-46

A few considerations.
When Relyvrio was first rejected by the FDA, the lobby group pressured then to change the outcome - but it was eyes wide open. The EU never gave it a green light and the FDA made it conditional - in other words, there was absolute doubt but in the absence of anything, it was something and to many, worth that risk.

When we go to the next phase, it will be at pace because it is a desperate gap in health care BUT it is not without the data for safety from all previous trials and data sets (Eli Lilly/Elanco included).

When we go to trial, the FDA has the benefit of hind sight.

When we go to trial, I am making the bold projection (given they are all represented on our advisory panel) that Berry Consulting, TRICALS, Healey along with existing Safety and scientific folks here in AU will all be leaning in to ensure our trial design is of the highest standard and our data collection and processes are beyond reproach.

One observation is that this is a VERY sensitive community. These people dedicate their lives to making the lives of NMD/ALS patients better. They want nothing more than for Monepantel to be successful but it won't be at the cost of their patients. So I trust that they will never take unnecessary risk for the patients.

So is i too fast and not researched enough - NO... The body overseeing us scientifically would never allow such recklessness.

Adreamer