PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Spideyboy]

Reading into the Terminology of the Press Release I do note this statement. "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."

Looking at the FDA site about CRLs and reasons for giving them out. The 4th reason stated is "Recommendation of actions for approval". When possible, a complete response letter will recommend actions that the applicant might take to place the application or abbreviated application in condition for approval."

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110#:~:text=If%20FDA%20determines%2C%20after%20an,or%20reviewing%20proposed%20product%20labeling.

The other 3 reasons are

(1) Description of specific deficiencies. A complete response letter will describe all of the specific deficiencies that the agency has identified in an application or abbreviated application, except as stated in paragraph (a)(3) of this section.

This seems to refer to general deficiencies, which hopefully can be quickly resolved.

(2) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed. The complete response letter will identify any amendments that the agency has not yet reviewed.

This paragraphs isn't really relating to any issues per se, just mentioned about amendments to be or not yet reviewed. So this doesn't seem an issue per se.

(3) Inadequate data. If FDA determines, after an application is filed or an abbreviated application is received, that the data submitted are inadequate to support approval, the agency might issue a complete response letter without first conducting required inspections and/or reviewing proposed product labeling.

I don't believe this should be the case as the FDA had an initial review of the data before giving it Priority Review. Also we note here that "Inadequate Data" reasons would be given before conducting required inspections.

Given that we have not heard anything this time about inability to visit the manufacturing sites as in the prior delay PR, then the FDA would have conducted an inspection, this "Inadequate Data" ratiole should not be the issue.

This logically would leave us with "Recommended Actions for Approval", which, which again mirrors very closely the terminology in the PR, "additional actions required to obtain approval".