PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Kronberg]

All these are good points but I heard another very encouraging phrase- patients' transition to PRX-102 may delay kidney dialysis for 5-15 years.
You probably don’t read ST now. Have a look at what I found relative to PRX-102 Orphan Drug Designation status from EMA.

“One criteria which is specific for Europe is that when coming to the market, the drug must either be the first in its kind for this specific disease, or if other medicinal products or methods of treatment exist, like surgery, the new orphan drug has to be in some way superior or show significant benefits, meaning it will change the life of rare-disease patients.”
“In general, we shouldn’t compare the European and U.S. systems, simply because we work under different legislation,” she said. “With so many member states, we have to reach a consensus. Everyone discusses and then votes. That’s very different than the way the FDA comes to a decision.”

V. Stoyanova chairs the EMA’s Committee on Orphan Medicinal Products.

https://fabrydiseasenews.com/2020/02/05/post-brexit-move-amsterdam-completed-ema-now-renews-rare-disease-focus/

So, the consensus for PRX-102 was reached by experienced doctors from different European countries.