SENS - Potential FDA Approval Play

SENS is a stock we’re all familiar with. On January 5th, they announced that they were anticipating approval for their 180 glucose monitoring solution within the “coming weeks”. That decision could be any day now according to that statement:

For a greater DD on SENS, see @Shamu’s comment below:

As usual, this thread is a wiki, if you’d like to expand on this shorthand stub, feel free.


Considering this and the market downturn, I’m taking the opportunity to average down a little on my SENS position and establish some short term and longer term call positions as well.


Bless :pray:t4:


I thought I would add the OI for the upcoming OPEX; it seems to mirror the positive sentiment. I am following this play.


Wish you all luck, but personally I will not touch another FDA approval play ever again. Look at AQST as a cautionary tale.


Not saying not to play, I have a couple feb 2.5c I bought today, but HGEN was another lesson in the dangers of FDA approvals. Consider them gambles. HGEN was also confident they’d get EUA approval for their drug.

ETA: the SESN forum was an absolute wreck the day they got rejected as well, stock tanked from I believe $4+ to <$1.


As someone who lost a shitload of money on HGEN back in September, I agree with the above. Only spend what you can afford to lose.


I appreciate the comments warning caution but SENS is a bit different of a candidate. I understand people often get burnt by these approvals and the same considerations apply in some respects, but not all approval plays are created equal and we should be mindful to consider that.

SENS is seeking an approval on a product already approved in Europe to my understanding. So the chances of approval in the US are somewhat higher I would imagine. Also SENS is a company that is already actively making money and is trading near lows.

I used to know a bit more about the company in early 2021, but have forgotten most of it, so if one of our biopharma experts would like to chime in, or if there is a pertinent bit from one of the archived DDs that someone would like to copy over, it would be much appreciated.


Correct. Already approved in EU and to my knowledge is favored in Europe, it’s where most of their revenue is coming from currently.


Have been telling Whiplash that I’ve been going to play this. The two times they’ve reach $4, I became fairly profitable with around this $2 range.

I feel that it’s likely we’ll see a larger buy come in at one point due to the expectation of the approval. We know it’s going to happen, it’s just a matter of when.


Good to know, I didn’t know anything about SENS and just took a gamble position. I’ll do more research and maybe add to it.


Got in with some shares, had good luck with the last “already approved overseas” though that one was Japan.

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I’m going to jump in here too- will either be doing Shares or long(er) options.

It says as much in the article but the FDA is majorly backlogged. I have multiple customers. AVDL being one (another Valhalla favorite) that have seen their approval dates come and gone with no indication from the FDA on when they will get around to making a decision.


Thanks for the info, got an order waiting at 2.


I will say that in general, EU approval is as difficult to get if not more difficult than FDA approval. UK approval is generally considered to a bit “less stringent”? So that is certainly good news for the stock. HGEN was a play and remains a play that has no current approvals and is not making money. So Conq is absolutely right that all approval plays are not the same.

My two lessons I learned from approval plays in 2021: (1) be cautious with companies who do not already have other approvals or other products on the market (high reward but high risk); and (2) do not get overly optimistic about how high a company’s stock will go upon approval (saw this with OYST and VBIV). Sometimes the market remains skeptical of whether the drug approval will lead to massive revenue.


Out of curiosity - I would assume “shorter” and “longer” is in relation to the estimated approval date - how far out are your “longer” positions?

Well I took shares. But I guess shorter and longer are subjective.

Longer to me here would be 2-3 months AFTER you anticipate approval. They said “in the coming weeks” which could mean anything really. I choose to believe that means end of February-Early March. Before shares I was looking at April-June calls.

That way you can react to the news by selling on approval- and you have some cushion if it gets pushed.

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From my previous SENS post and like Conq said - Shares are also safer play on this than calls, but SENS is expecting FDA nod for Glucose Monitoring System in the coming weeks. However, this has been one that has been waiting for FDA approval for a bit. I started a small starter position on Feb calls (edit I averaged down on them today and bought new ones that are farther out to give more time. Bought at bottom today and they already up about 30%. I know, thank you market, but still todays entry was much safer than my previous that I averaged down. Support around that 2.50 area and 2.10 area currently, previously support was 2 and lots of resistance at 3 then major at 4 level.


I initiated some Apr 14 calls in SENS.

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Added to my calls at this $2.30 level.