RE:RE:NEWS!This is only speculation from me, but I always believed that the BLA for plasminogene was a safety and bioequivalence of our Pg to be prooven real 100%pure human PG.
The fact that pg trial met both 100% endpoint on Pg CD with no side effects makes a good case to proove bioequivalence and brings what is needed to get the BLA.
So the use of intravenous PG to treat hypoplasminogenic or any other condition where level of PG in human can be controlled in order to treat a related problem might really be just be a kind of phase 4 trial since Prometic Pg will have a BLA authorising the use of PG on human.
I am probably not being clear, but Pg is not a chemical compound. It is an innactive human protein that travel freely in the plasma of a normal human and becomes effective by transformation when needed by the body.
If the BLA for PG allow the use of PG intravenous to normalise th Pg level in PgCD, then the way to go to use Pg for other treatment where concentration or local delivery of PG might really be a simple phase 4 short trial.
PL did not mentionned phase 4 trail for fun. There is someting special with Pg use since it is a Human protein and not a chemical compound.
The Pg usage pipeline is growing very large. Once the BLA is granted, the market, mostly the US market (nasdaq) should start to wake up and as said Himmler, a RS should allow big fund to invest in Prometic and get the SP where it belongs and throw away the shorters and the small traders who don't understand the complexity of this industry.
Just my opinion