Why Meso is pumping today?, page-62

Did MSB get FDA input into trial design, lopes? And which trial was this?

I can't access the one from 2015, as the link from their website is behind a paywall.

In 2013, the did a small phase I/II trial in Japan.

Another trial, published in 2013 was a larger multi centre trial based in a number of countries. Was this the one that sought FDA input into trial design?

Genuinely curious. I've read the available studies and they don't mention FDA guidance. Maybe the one behind a Polish paywall?

If we are accusing the FDA of gross misconduct it would be good to have some evidence.

I've got to be missing something, maybe the website isn't comprehensive.

Maybe management didn't get FDA guidance, and now it's biting them in the butt. Why didn't they think this far ahead? Maybe Novartis can come and help with trial design.