Today Biovica International published its annual results. There are important quotes in the CEO comments that investors should focus on:
“We are following our schedule for being able to launch DiviTum®TKa in the USA during the third quarter 2021 and utilizing the time prior to approval in the best way possible.”
“Our application is one of the few that the FDA resumed its review of, already back in January. Because of that, we are sticking to our goal and remain confident that we will obtain 510(k) approval for DiviTum®TKa during the third quarter of 2021, even though the FDA 510 (k) reviews for IVD products in general have been significantly delayed.”
The study results provide another strong indication that DiviTum®TKa has great potential beyond our initial area of metastatic breast cancer.
Link to the results:
There is an investor call tomorrow at:
When: 18 June 2021 at 10.00 CET
Investment idea summary:
- Biovica has 12 studies including most prominent US HOspitals (Stanford, Mayo , Cleveland ) that show the product work
- FDA is due to approve the product in Q3. Pareto Securities view on this: “…it could occur any day, is becoming more likely that it will be delayed into August/September“
- The company today announced that it will start selling the product in Q3, shortly after the approval
- Pharma companies, that have a major milestone in a near future achieve significantly share price appreciation. Xbrane double in two months on positive Phase 3 data study expectation.
- The 12 study from best hospitals reduces risks for FDA approval. Biovica is perfect candidate to double in the next 2-3 months.
I am long Biovica. I like that the mgmt is long too with 18.3% stake.