I believe SI and the team were aware of the FDA's concerns...

I believe SI and the team were aware of the FDA's concerns regarding efficacy, hence the ODAC meeting and were confident they could prove their case that Ryoncil is effective.

This their confidence seemed to be well placed as the ODAC panel voted 9-1 in favour of efficacy. From this Mesoblast and the public were clearly confident that the FDA would follow the advice of their own independent expert panel stating that from the available data the product is effective.

However, the FDA decided to go against the overwhelmingly positive vote on efficacy issuing a crl requesting further information (ie. a randomized trial), the first time ever going against an overwhelmingly positive ODAC vote.

I believe that the judge will think it was quite reasonable for Mesoblast to state that in their own opinion they were confident of approval given the overwhelmingly positive 9-1 ODAC vote on efficacy.

Unless the prosecution alleges that there was inside information on paper that stated approval was unlikelyfrom the FDA which wasn't published or made aware of before the crl then there is no case here.

Also you are incorrect in terms of the legal cost to msb as the article i previously posted mentioned that the self funded retainer insurance which msb would certainly have does not require any minimum value before it kicks in, simply msb are covered for any legal costs upto $1m+.

Also don't worry Ryoncil will be approved, its not a matter of if but when