Only dead as we await news. We have a decent idea what news is going to come out and we know when to expect something.
- Update on second Type C meeting with FDA on Accelerated Approval. This is meant to happen this quarter, so we'll probably hear about it in the next earnings call, or perhaps a PR before.
- We know they are effectively focused on completing PRX-102 successfully. 110 on the back burner, and 106 deciding between partnership or go it alone for next clinical development. This decision will probably be based on outcome of next FDA meeting as this will already outline potential Chiesi milestones if AA approval can be had earlier.
- They have stated that they have the funds to get to AA submission and approval, or normal submission (in EMEA) if AA is not granted. Though reading the updated draft guidance, the history of US Fabry products, the efficacy seen so far as well as positive patient and physician reception of the product, I don't see why AA would not be granted.
Main concern I feel is if they go with the next phase 106 development without a partner and without AA.
Regarding upcoming news, I'm also hoping for an update on the Bright study to; a) show they already recruited the last remaining patient (which they should have done by now) and; b) interim eGFR data from Bright which I believe Moshe alluded to during the last call. However the eGFR data should be decent as Moshe mentioned all patients that completed Bright and with the consensus from their physicians have decided to maintain on the once monthly dose rather than go back to Fabryzyme.
Regarding the trickle, I'll be looking to buy more, as long as we get the AA designation, then post hopeful AA designation the small bump in SP will remain low and I feel should be a particularly good time to accumulate.
Yossi mentioned that in the last Type C meeting, they discussed PRX-102 in general for AA designation and the FDA informed that Protalix could use the surrogate endpoints and eGFR. Yossi then mentioned that the upcoming Type C would be to delve deep into the specific PRX-102 data for AA. Thus that means if the company receives positive opinion for AA this should mean the FDA has at least been happy with the deeper data and increase chances of AA success.
The science and it appears the funds are there. Just a little longer.
