PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Spideyboy]

ON the topic of Accelerated Approval, I had a look into the timeline for this.

The target Accelerated Approval review timeline is 6 months.

http://www.pharmexec.com/how-fast-are-fda-fast-lanes

Also when looking at a fabry candidate drug that was looked at for accelerated approval we can see the FDA target for review again was 6 months.

http://www.pmlive.com/pharma_news/sanofi_gains_accelerated_review_for_rare_disease_drug_722639


Given this being the case, and that PLX mentioned holding discussions with the FDA for Accelerated Approval in 1Q 2019, may mean that if they submit the documentation in 2Q 2019, that we could have PRX-102 approval by end 2019. Again as mentioned when looking over the new FDA guidelines and that Fabryzyme and Galafold were approved under the Accelerated Approval pathway, that I would feel this would seem a strong possibility.