From an MD/Prometic investor ...
Intensive Care Off Label Indications
' From my perspective as well, I expect off label Pg to ramp up quickly after approval. I was initially skeptical, but after attending the AGM I am confident it will move quickly, especially in the 'intensive care' indications -- in burns first, and then ARDS, and massive trauma/blood loss. Burns are a 'no brainer' as there are robust animal models showing amazing healing -- and prevention of the burn wound becoming much wider/deeper -- with Pg administration (pig model at AGM). It isn't complicated -- the massive inflammatory response causes blood proteins to get consumed -- if you replace a very important one, Pg, patients will do better. Burn centres are also highly regionalized so our teams should be able to reach them quickly. ARDS/ALI (essentially lung injury as the result of massive inflammation in the body -- from trauma, burns, pancreatitis, systemic infection, etc -- all the inflammatory mediators and fibrin in the blood secondarily damages the lung) is very common in level 1 intensive care units, and probably accounts for a third of all intubated patients in these centres. Again, massive inflammation consumes proteins, and we would be replacing an important one in Pg. ARDS/ALI is a huge indication, which also means time for uptake and maybe something that would be hard for us to go alone. My main take-away from the meeting is that we are poised to get out of the gate running with Pg, both with congenital deficiency and wih 'intensive care' off label indications. '
Jim |