OpGen Inc (OPGN)

[boston127]

Picked up some more today.

Just bought a few at 3.67. The selling this morning was very strong, but we held the recent gains and are now heading north again.

Three points why I like this investment:

1) They could have increased the AS a few months ago, but chose not to.

2) They recently beat the analysts' earnings projections.

2) The FDA is ready to approve this technology.

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.