OpGen Inc (OPGN)

[boston127]

You do not understand.

The FDA is ready to approve this technology. Of course it is not yet ready for sales and distribution - yet.

In June, we submitted an updated 510(k) summary to the FDA for our Acuitas AMR Gene Panel for isolates. The FDA had previously provided substantive feedback on what we believe is all key documents, including the package insert, electronic user guide and operator manual, in line with their currently expected timeline of doing so by the end of May. The FDA recently reiterated to us that it intends to complete its review by the end of August of 2021.

Since submitting our revised documents to the FDA, we have not received any additional feedback nor questions or requests for additional information. Although the FDA clarified that their timelines can be affected by various factors, we're confident in the progress moving us much closer towards reaching a final FDA clearance decision point in the coming weeks based on the FDA's current expected timeline.