That is in ref to full/partial clinical hold(s)--NOT the BLA
Also be aware--that is author said--that Cyrus said--NOT FDA said
As stated before--a FULL disclosure of ALL correspondence will show any/all issues that resulted in hold (S). This will reveal IF these issues can be mitigated corrrected and what sort of $$ and timeline will be required. This will also SHOW EXACTLY how honest "new" mngmt has/is being. Not holding breath. Already know on several occasions Tonya/Cyrus have stated "there are no more questions" and "thats all we have time for". Out and out lie.
And what facts do you use to judge that the current management isn't terrible? What has Cyrus and crew achieved in the last 8 months he's been on the job? Do you take it on blind faith that they have actually submitted those documents? Nader also said they had meetings with the FDA and submitted a HIV BLA, but he left out the part that it was a known incomplete submission. How do you know this current management isn't lying like the last one?