Biovica – My discussion with the management on the FDA approval process

I reached out yesterday to Biovica on the FDA approval.

Question

I read your announcement and all the research and info on the FDA delay. May I please ask how this works? Will FDA give you a signal that you are back In the review process?

Answer

Some background about the FDA process. We submitted in September 2020 and passed the two first milestones in the FDA process, see this link: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process#timeline

So, since October 2020, we’ve been in Substantive Review phase. However, at the same time, we got the feedback about the 90-day delay, since the FDA re-allocated all their resources to Covid-applications and put all others, including ours, on pause.

After ~80 days into the pause, in mid January 2021, we got the information that the pause would be extended with 90 days but the FDA opened up for an opportunity to come in with feedback to argue for why our case should be one of the few that they prioritized re-started earlier.

So, we did that and submitted a strong case for DiviTum and our case. That resulted in positive feedback from FDA as they on the 29^th January 2021 officially reopened the review of our application.

However, nothing happened until end of May 2021 when we got a lot of questions from the FDA. We then did an SIR submission to be able to meet with all FDA experts to discuss the questions raised by the FDA. During this process most of the questions were resolved and only a few questions remained to be discussed and answered. The FDA then gave us feedback that the remaining questions would be resolved interactively, which we thought was very positive.

However, during August and September the FDA couldn’t provide feedback quickly, it often took them several weeks, due to their high workload, which is a result of the backlog caused by the pandemic situation.

In the last weeks, we have provided feedback requested by the FDA, and we’ve been able to sort out several of the open questions which we now are waiting for feedback on from FDA.

Given the current backlog due to the pandemic situation, it is difficult to give a forecast, as we’ve given all the input we’ve been asked for and are waiting for the FDA response. The next step after the FDA feedback is for us to submit the updated application and hopefully the next step should go smooth as we’ve sorted out all open issues with the FDA.

My summary from the above:

Biovica is waiting for a feedback from the FDA on last open issues. That could come any day now. After that they will submit updated application, which should result in FDA approval. Pareto and ABG stated that they believe the FDA approval may come as early as October. For the value of the stock, it is not relevant, if that happens two weeks or two months later. The relevant issue are:

1. The likelihood of the FDA approval is very high – Pareto gives this 95% probability.
2. After the FDA approval the share price should re-rate strongly
3. There will be further material catalysts right after approval – mainly the imminent start of the US sales and agreement on reimbursement with US insurers (expected within two months of the approval)
4. In 2022 Biovica will file application for other cancer tests
5. I spoke to the analysts, they believe that next year Biovica shold become a takeover target. Redeye has a bullish scenario over 300 SEK. It is not unrealistic, that we could see this share price value next year

I believe Biovica offers the best risk/reward in Scandinavian Healthcare. The share price should at least double this year and potentially multiply further next year. If you doubled your money playing Xbrane with me, this ride will be even better.

Full investment thesis:

https://seekingalpha.com/article/4437698-biovica-international-should-double-on-novel-breast-cancer-test-launch-in-q3