Here you go King.It is a huge submission. Simply indexing the...

Here you go King.

It is a huge submission. Simply indexing the BLA is an onerous task - it is over 100,000 pages. They use an external publishing company to put it all together.The new potency data would probably be updated in multiple sections of the submission i.e. in explaining the old trial data, in the CMC manufacturing section, in the quality controls, inventory etc.The FDA don't sit down and read it page by page, they use the indexing to find the things they are interested in and then read them.On 26 March, SI said they intend to file "in the next quarter", they didn't say "in the next month" so they have given themselves until June 30.Apparently, they indicated to Bell Potter that the resubmission might happen mid-May, while that might just be the analyst guessing, he has direct access to SI (though many people will tell you that direct access to SI doesn't help much as he tends to be overly optimistic).The resubmission "will seek to address all remaining product characterization issues" - as I've said several times, we still don't know exactly what those issues are or what the FDA's exact problem(s) is. Meso does itself no favours with this communication style - it is never cut and dried, and for several years I have cautioned people not to expect results before the latest possible date mentioned by SI - in this case that would be June 30. Maybe it will come sooner, but the track record on delivering earlier is not good.

ET

Aloha.