I listened twice to the Lifesciadvisors webcast with Dr. Warnick. As low key as it was there were some interesting tidbits that are good to know:
1, Home infusions in the trial kept the trials going (because of covid) and will be very helpful in the future.
2, Much less infusion reaction is an important patient positive which alone will stimulate switching to PRX-102.
3, He appeared to be thrilled to have been part of an actual comparative study and potentially have a better treatment option, rather than telling patients US patients he has only one treatment option to provide.
4, In response to a question at the end, PRX-102 does not reverse the disease but PRX-102 better slows the decline vs Fabrazyme and improves the quality of life.
Other matters of importance:
1. It was the FDA that changed the study to non-inferiority from inferior because they officially approved Fabrazyme recently.
2, I though Dr. Warnick was very clean in saying that there is nothing being developed by others (such as gene therapy) that is anywhere near replacing ERTs as Fabry treatments. Looks like if approved by early next year PRX via Chiesi will have years to have Dror's predication of a potential $1 billion royalty stream a reality.
3. PLX has plenty of compacity now and in the future to meet demand.
4. PLX believes if approved it will include both the twice and once monthly treatments. There are now 150+ patients in the extension studies which include both twice and once a monthy treatments.
Conclusion: We just have to wait for the approval process to run its course. Hope this summation is helpful and will convert traders into long-term holders of PLX.
