RE:RE:Breakthrough therapyDryBones wrote: It was stated a year ago at Medica research .com that Prometic's Plasminogen was a potential "breakthrough" therapy.
There is such a designation by the FDA and it is even more out of the ordinaryl than orphan drug status, and gets even a faster review.
Apparently we never got this designation. Does anyone know any different? I'm suprised that the self proclaimed experts on this board, of whom there are many, have not jumped all over this question. Surely they all know more than me. They've said so.
https://medicalresearch.com/author-interviews/breakthrough-treatment-with-prometics-iv-plasminogen-treats-rare-disabling-disorder/38972/
All these "designations" PLI has "received" from the FDA amount to a bag of ****. Its all hype pumped by the pumping team here, as none of that previous FDA stuff has mattered one iota in terms of getting any PLI product to market. All the hype about breakthrough therapys and orphan designations and VOUCHERS - wheres the daily voucher talk!! - has amounted to exactly nothing. Fact is Pierre and his brilliant management team TOTALLY dropped the ball hard and FDA spanked him and all of us. None of their fluff will get us out of that hole, PL needs to be called out for not being prepared properly.. how that is possible given the "constant communication" that was bragged about is beyond me... and YES, I have saved those emails bragging about the constant communication with the FDA... So weak.