Sorrento Therapeutics Inc (SRNE)

[dia76ca]

SEMDEXA approval process is getting close. The 10K said...
"The SP-102 pivotal Phase III trial 12-week data demonstrated a highly statistically significant greater effect over placebo for primary and secondary endpoints with no safety risks identified. The complete six-months data analysis is expected by March 2022. Based on the current results, we plan to submit a request to the FDA for Breakthrough Therapy Designation, which will help expedite the overall development program and potential market approval. We also expect to submit a pre-NDA meeting request to the FDA in the first half of 2022."
Sorrento already has Fast Track designation for SEMDEXA but Breakthrough Designation and priority review(WITHIN 6 months) requests can be expected.
The Scilex marketing team is in place and late 2022 or early 2023 sales are not out of the question IMO.