Post by
Gorf79 on Jul 19, 2022 1:01pm
Expanded Access for New Investors!
In 2016 Spectral's PMX was granted an Expanded Access designation by the FDA.
This used to be called a Compassionate Approval, meaning it could be used for Sepsis patients on compassionate grounds. Yes the FDA saw the benefits and granted this approval which I am 99.9% sure is still in place as Dr. Kellum mentioned it in a recent presentation.
Combine Expanded Access, with 250,000 RWE uses, a 100% safety profile, excellent segmented Euphrates data, the Tigris trial greatly exceeding expectations, major league trial sites and the Breakthrough Designation and it demonstrates PMX is a LOCK for approval!!
Yes it is a LOCK!
Comment by
Gorf79 on Jul 19, 2022 2:05pm
On top of all those immensely positive developments for PMX there is also the fact that Baxter has launched Spectral's PMX to both their shareholders and massive sales force. Chew on that for a bit! It's a done deal gentlemen..,
Comment by
mercedesman on Jul 19, 2022 2:23pm
Now if we could just get expanded access TO new investors. ...so at least we get closer to the low-balled Paradigm Target, before the (first?) BIG asset Sale. MM PS Where's Walden ?