$SENS incoming FDA approval?

Okay I’ve prodded for opinions on Sens for a while, but I think the time has come for the FDA to finally get around to approving their 180 day CGM. They filed for approval and we’re assigned a reviewer in late April and typically once a reviewer is assigned it takes ~6 months to receive feedback (approval or not). Seeing as the 180 day CGM is already successfully in use in Europe and generating most of the companies revenue, along with the study that came out about its efficacy in June, it would seem highly unlikely that the FDA would not approve the 180 day CGM. Why has it taken so long for FDA approval? Not sure but probably because of covid swamping the fda and other bureaucratic/administrative bullshit. As far as the company goes on fundamentals I’m long on it but that’s besides the point. I’m new to options trading and have been learning from everyone in this community. I see an opportunity here based on my own knowledge and DD. I think upon FDA approval we could see Sens go from ~3.50$ to 6$ or higher. Seeing as were already 5 months out from April and hedging that the fda gets to this ~6 months that would make November and December calls potentially very profitable. I have a few January calls I bought before I really thought about the timeline and I recently added some December 4$ and 6$ calls. Let me know what you guys think and please provide feedback as I am still learning and new to options. I haven’t done much of a chart analysis but it does look to be approaching a reversal.

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I’ve been holding January 4c for a while. I also think that the approval is coming up soon. My understanding is that the only reason the FDA approval got delayed was because of priority for COVID-related approvals. It should be noted that SENS’ business update on December 23, 2020, said the following:

We remain confident that the PROMISE study demonstrates that the excellent performance of the current Eversense system is extended for up to 180 days, and that there still is potential for a decision from the agency by the end of the second quarter,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics.
Source: Senseonics Announces Business Update – Senseonics

They expected approval at the end of Q2. We are now in Q4. My bets are on January calls. Alternatively buy the shares and overcome theta decay :slight_smile:

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Will read this when i get a chance thank you posting setting a reminder :slight_smile:

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Learning About the Longest-Lasting CGM with Diabetes Care Expert | We're live with Ascensia Diabetes learning about the longest-lasting continuous glucose monitor (CGM) from diabetes care expert, Dr. Francine R. Kaufman. | By JDRF | Facebook Some SENS info that could be helpful, at 27 minutes she talks about the delay a little

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She just says it’s taking longer to get through FDA because they’re giving priority to pandemic drugs. Still no time table.

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I got some options expiring in Jan 2022

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are we finally going to see approval? lol.

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https://finance.yahoo.com/news/senseonics-announces-business-updates-214500473.html Expected in coming weeks… but that probably means April lol

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weeks in SENS talk could be months. :sweat:

Hopefully this press can help me back to BE w/ my jan calls. Interesting to see the SI, curious how this will play tomorrow. Certainly going to be interesting.

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Yeah the SI is significant and the OI chain is actually kinda jacked but the float is large so idk how it will impact

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Just copying this here, SI is currently 10x the average daily volume and the shorts are close to going underwater.

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Yeah if FDA approval actually does come within coming weeks it could cause significant movement imo

Their approval is quite on the card as discussed in the post. So I think it will be a “sell the news” event since it’s not a binary event. Better ride the wave before the approval.

Agree but if approval comes sooner than “a few weeks” Is where wed see a pop. Otherwise it’s as expected “in a few weeks” and becomes a sell the news event