Pfizer owns the market with Heparin. Yesterday they heard what we did: Neutrolin is 72% more effective than their flagship product. Not maybe. Not possibly, but statistically proven.
LPAD, if granted, is going to require a tight window to get the product to market (not a statutory construct, just a hunch...as the other firm given LPAD designation in 2018 had product to market in less than a CY quarter later).
Looked at another way, why would the FDA give the LPAD designation only to have a small 17 person company dither for up to an additional year ramping up production before they could bring it to market. As I’ve said before, they don’t have that kind of muscle. They will need help.
If you are Pfizer or another player champing at the bit to get into the space (or to pair with one of your flagship products in oncology, for example), yesterday you watched as a little boy (or girl) walked into the classroom with an 800 lbs gorilla, named Neutrolin, for show and tell. What then, do they do?
I could be totally wrong. And maybe CRMD goes on the road to raise capital and build an entire infrastructure around then product. That’s at least a year away. At least.
Then why bother with LPAD? The request for designation for an ‘urgent need’ only to wait 12-18 months to deliver said urgent need? That makes no sense. For both CRMD and the FDA.
Anyway, that’s my personal opinion. All the pieces are lining up perfectly except timing. That gap needs to be filled in order to execute a proper roll out.
At least that’s the way I see it.
GLTY.
