That was explained to have been done months ago. We were not waiting for this. The publication on the website may have been a final thing just like patents are often approved but there are final administrative steps that make the approval final or public. No such events typically exist fir the FDA approvals of IND’s ir SAP’s unless, at the beginning, you get a very special thing called an SPA (special protocol assessment), which has been discussed here before. The company has had basically an adaptive trial, and if they had had an SPA, and I am not sure those even existed when this trial began, then they could not easily adapt the trial without losing the assurance of the SPA, which some large companies have done because the adapted SPA was simply better than what they had originally proposed. There was an example of that very thing discussed in this site at one point when another member tried to confuse people about SPA’s and SAP’s.
You don’t typically PR such changes. And as I wrote elsewhere, just because the EU clinical Trials site is maintained by an agency, and they only publish once the SAP is “approved”, it doesn’t necessarily mean that that approval for the final assessment is any more firm than it is at the FDA. If there are reasons not originally anticipated that throw a trial into question, you can bet the EMA is as likely if not more likely than the FDA to raise those questions.
I don’t think any of that is likely to happen in this case, but we’ll see.
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