PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Spideyboy]

Listening to the call again, it's true that Moshe didn't specify that the over 110 were in the Phase IIIs but he says, 'across all the studies including PRX-102', so yes you are correct.

I wouldn't say that Fabryzyme and Galafold don't have approval, more that they received approval via Accelerated Approval for which in both cases GL-3 levels in kidney cells acted as the surrogate biomarker for approval. And where both were compared against placebo. Whereas the apparent superiority we are seeing of PRX-102 isn't simply against Placebo, but against the key current treatments, which is much more meaningful if proven to be superior.

This fact that GL-3 type of biomarker approval was used for Fabryzyme and Galafold approval is a testament to the need for treatment for Fabry. However, PRX-102 appears to not only help on such biomarkers but even more importantly seem to be able to significantly slow or even reverse the kidney degradation eGFR slope which is the ultimate killer for most of these patients. Thus the PRX-102 data is more meaningful as an approval end-point.

If PRX-102 gets such Accelerated Approval, or really meaning faster review process I think would be likely based on the above mentioned reduction of GL-3 and also the apparent impact on eGFR. If approved based on these metrics combined I would understand this to be significantly superior data and thus advantage over both current ERTs (Fabryzyme, Replagal) and Galafold.