ABG Sundal on Biovica: “Closing on the finish Line”

ABG Sundal Collier just issued their update on Biovica. I include the full report below. Very bullish

There are two major points in the research:

  1. During the quarter, the company has interacted with the
    FDA and undergone a Submission Issue Request (SIR) process . This is
    a routine way for the FDA to resolve or clarify minor issues or questions
    that have arisen during a submission process.

2. The company has compiled all the additional data and plans to send it to the FDA with an SIR in early September. The company expects that the FDA will provide feedback within 21 days, which means that a response should be received by the end of September.

The response should lead to either: 1) a 510(k) clearance or 2) a request for additional data and a slight delay of the process (months).

The management on their annual shareholder meeting video (available in 29/8 post on this blog) stated, that they believe FDA will very likely give their approval in September. If they are right, we are up for a strong re-rating shortly.

I am long Biovica. Since I first wrote about it, the stock is up 50% (from 40SEK to 60SEK). My price target for the stock in Q4 is over 100SEK. Very attractive short term upside in my view. Very similar situation to Xbrane, which under same situation increased from 70 SEK to 160SEK. I believe Biovica will be similarly good.

Link to the full ABG research:

Interesting article on Hofseth Biocare

See my Friday blog on HBV. Pls also see the investment story on HBC. The company is now growing over 50% yoy. The growth is likely to accelerate further. Quite interesting opportunity. I am long HBV.

https://seekingalpha.com/article/4390174-top-value-creation-play-in-biocare

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