The selling was due to the Biovica s press release stating that FDA is in delay due to the Corona Virus work overload. I enclose Pareto Minutes of the call with the management published minutes ago.
The minutes indicate, that there is no justification for the sell off. The Biovica value does not change whether the approval is this months or next month. Pareto believes the delay will be only by one month – approval should be coming by the end of October.
I am long Biovica, i have been buying more this morningn.
|FDA’s handling delayed, call with CEO|
|Biovica today announced that there has been a delay in response from the FDA. In a call with the CEO this morning, it was confirmed that nothing new came up but that it is just an FDA-related delay. After the last meeting with the FDA, the company received the meeting minutes and prepared an answer based on all requests with minor questions surrounding the intended use to be discussed interactively (a point where a company usually aims for wider claims and the regulators wanting everything backed by data / keep the intended use narrow). These are detailed questions/negotiations surrounding the broadness of the intended use and there have been no questions anymore regarding predicate device, this has been solved early on. The FDA however has not come back yet on these intended use details, so the company is still waiting for them to ensure the best possible outcome of the submission/widest possible intended use for DiviTum. Based on these insights, we see no increased risk of a rejection of Biovica’s submission. As previously communicated, we expect approval before end of October, with additional delays depending on COVID-19 related regulatory workload for the FDA. We reiterate our rating on BIOVIC with a target price of SEK 103.|
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