Ann: Change of Director's Interest Notice - Silviu Itescu, page-122

October 2020 was in the middle of the pandemic with consequences for clinical trials across the board.

Tricky?

Why is it necessary to have a double blind trial when the trials so far show inversion of the death rate?
And that death rate of around 80% is so high it can be used as a baseline.
The logic on this is inexorable.

In these circumstances having a Double blind trial is unethical.

I'm not singling out any particularly difficult members of the FDA, but saying they have "a few quips about this one" is pretty lame at best.

They aren't even coming out of the pandemic and they slug MSB with quips and hide behind authoritative sounding quotes.

In God we trust? The rest must supply data?

I trust nobody in here or the FDA for that matter, that persistently refuses to exclude what makes stem cell based therapies unique and what makes the FDA position so untenable.

Also changing of the guard was at the top, it takes a long while for the rat to be digested.

Rats in the lower ranks with a bias towards old and inappropriate ways of looking at things, are a scourge and not easily dealt with.

It's why the FDA has finally, finally issued a consolation paper which uses MSB's approach as the way forward.

Let it sink in mate. It's still full throttle with the disinformation and sound bytes.