PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Spideyboy]

Well now we know, CRL and issues to fix

Protalix and Chiesi are studying the CRL to assess the most expedient regulatory approach to reach an understanding with the FDA on additional actions required to obtain approval of PRX-102, and will provide an update soon.

"While disappointing, we remain confident in the strength of our data and in the depth of our program," said Dror Bashan, Protalix's President and Chief Executive Officer. "We remain committed to the program and to working with the FDA and Chiesi toward the approval of PRX-102."

"Based on extensive clinical data including results from the Phase III BRIDGE clinical trial of PRX-102 for the proposed treatment of Fabry disease, we continue to feel strongly that PRX-102 is an important option for the treatment of Fabry disease in adult patients, and we are continuing with our efforts to make this therapy available to patients," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases. "We thank the patients and clinicians participating in our completed and ongoing clinical studies evaluating PRX-102. We are continuing to coordinate closely with the FDA to address and quickly resolve the deficiencies contained in the CRL."


https://protalixbiotherapeutics.gcs-web.com/news-releases/news-release-details/protalix-biotherapeutics-and-chiesi-global-rare-diseases-receive