Guggenheim presentation: quick notes
1. Feel confident that the Norse 8 design will provide positive data. Repeated the SPA message.
2. Norse 8 top line data in Q4 (question asked a couple times about 'when more precisely', Russ kept it to Q4) So I expect it next month.
3. Planning to resubmit in Q1 2025. Hoping for approval in Q3 2025
4. Separate process / submission for pre-filled syringes, they did not want to have more complexity when OTLK can have an approval for beva in vials. Questions around launching with vials did not seem to phase Russ, other companies have done that before.
5. CMC questions from the FDA: Russ indicated that 5 (6?) meetings were held with the FDA, where the FDA told them what was expected, how to submit the data, the type of data, and OTLK asked if anything else was required. From OTLK, that part is ready to go to the publisher. Again, OTLK seems confident they answered to the FDA satisfaction. There may be more inspections.
6. Even with biosimilars, OTLK is confident in their pricing approach (no price was provided during the call. Now Thermo shared the research note on that point)
7. Compound pharmacy: Talked about Pine being first inspected, have to recall, got out, then re-entered the market, got re-inspected, finally quit for good. When a compound pharma gets out, that part of the market is replaced by an approved on-label product according to OTLK.
8 Launch in Europe (what I was hoping would be a central topic): This was cut short, the webcast stopped as they were going through that. It sounded like OTLK is hiring (will hire? has hired) some sales in the UK and Germany, and that Cencora is also helping on the sales side and other logistical/regulatory aspects. Too bad this was not developed more.
Overall, nothing really new, expect maybe how they conducted the enrollment to be so efficient, being very involved in that part of the operation.
I thought it was a too short a presentation.
best of luck with your investments!
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