WHY SEMDEXA IS NEEDED...
"More than 60% of U.S. opioid prescriptions are for the treatment of chronic low back pain (CLBP)1 despite the fact that opioids are associated with serious and potentially life-threatening side effects and have not demonstrated efficacy in the treatment of CLBP. In 2018, more than 67,000 drug overdose deaths occurred in the United States5 of which almost 47,000 (70%) were opioid-related. Over 70% of the 70,630 deaths in 2019 involved an opioid. Provisional data released by the Centers for Disease Control and Prevention showed drug overdose deaths rose by nearly 29% over a 12-month period ending in April 2021, to an estimated 100,306."
And 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 US marketing team is in place and late 2022 or early 2023 sales are not out of the question. Sales could be $4-6 Billion in the US and even more in ROW!
"The refusal of the real is the number one dogma of our time" Rene Girard
