So, apparently they were working at AMAREX yesterday.
As investors we have to keep the facts straight and then, the interpretations, can give us some investment related decisions:
Data has been unblinded.
It takes few minutes to calculate the PE (mortality 28 days), few days to calculate/parse/classify secondary endpoints, in the release: “ and is in the processing of evaluating the data.
We had been told that FDA wanted to see the data once unblinded.
We are in in Discussions with U.S. FDA, MHRA and Health Canada
We have been told the discussions with the regulatory agencies are confidential
We have been told that the results will be reported when the Company has concluded its ongoing discussions with regulators
The question is: why the, positive or negative, data has not been released ??. They don’t have it (only primary end point) and some “hint” (whether advanced or primary I don’t know), of secondary outcomes.
Well, then, why they did not release the primary end point ???
This is where the part of the confidential
in the press release comes in:
Thanks to OHM who posted this: https://www.sec.gov/about/offices/oia/oia_cor...isclos.pdf
Under the general ongoing obligation approach disclosure may be subject to delay, to be granted in some jurisdictions by the competent authority, if:
(a) the information is confidential under legislation ;
(b) the information concerns an incomplete proposal or negotiations or the disclosure of particular information is such as to prejudice the legitimate interests of the entity’s investors; in such cases the listed entity must ensure that the information is maintained strictly confidential.
It might be that they are telling us: we are not releasing anything because we are in confidential
discussions with FDA.
OK. This is well and good, but, what about the data ???
For sure there is something to discuss with FDA. If the secondary end points are not fully analyzed there would not be discussions about them. So, either the primary end point (PE) merits a “discussion” and/or the other analysis is largely accomplished (and has "meat" ). Imo the PE does not have much discussion, maybe the Power of the trial would.
All-right, but let’s assume we crushed the PE. What would NP do ??? He would immediately talk to FDA and file for EUA and/or approval.
What if we missed the PE and have very encouraging data in secondary endpoints ? We would talk to FDA in regards to getting a EUA and ascertain what is needed for approval
What if the data is not encouraging ?? He would just do a press release announcing the data was not good and carry on.
So, we are in the two first points of above. The key question is: why is there need for confidential discussions before
releasing the (positive or negative) data when analysis is completed (the data, positive or, unlikely, negative, cannot be released because there are confidential discussions.)???.
There are two points that would point to positive data: the fact that in the very header of the release it was stated ” We are in in discussions with U.S. FDA, MHRA and Health Canada“ (why go to other countries if data is not-so-good and still in talks with FDA) AND if the results were negative they needed to be disclosed within days with no reason for further talks (confidential or otherwise) with FDA (and/or other countries).
The above imo.