Monday, April 11, 2022 1:46:15 AM
Here are some quotes from there
Analyst reports predict accelerated approval and give pegunigalsidase alfa a strong chance of outperforming Fabrazyme in the market. Clinicians in this publication spoke to see the potential for better immunogenicity and dosing schedule as key drivers of uptake regardless of whether outright superiority in efficacy is shown.
Even if eGFR improvements are not particularly differentiated among pegunigalsidase alfa and Fabrazyme, a MAJORITY OF PATIENTS WOULD LIKELY SWITCH TO PEGUNIGALSIDASE ALFA if a more infrequent dosing schedule is approved.
Without it (eGFR), immunogenicity and patient-centric quality-of-life measures will be key drivers of uptake.
https://www.clinicaltrialsarena.com/analysis/protalixs-phase-iii-asset-for-fabry-could-struggle-to-demonstrate-superiority-over-fabrazyme-but-immunogenicity-benefits-support-regulatory-chances-experts-say/
So, if we get FDA and EMA OK , the PRX-102 sales can be quite significant. You can get a good idea of the FDA by watching "Dallas Buyers Club" movie.
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