Probably a 7 out of 10 for me - if it wasn't for the coronavirus prospects which have just come on the scene this would have been a 5 out of 10 for me. I was very disappointed at the Hemodefend update where the IDE is now expected to be submitted / approved by Q4 2020, with the trial to start soon after. So you are looking at mid-2021 in what could have been a mid-2020 FDA approval for Hemodefend which was the company's best shot at getting something approved here in the US. It wasn't too surprising that they want to out-license Hemodefend to a partner but before they can even attract one they need to get this IDE approved and the trial underway with a data readout. The REFRESH II update was also another disappointment where they are hoping to restart the trial this summer and even if they do it would be a miracle for them to complete the enrollment by the end of 2021 so you are looking at 2022 for this potential approval. So the two biggest strategic efforts the company had underway for a pathway to FDA approval are continuing to struggle. It doesn't help not having a CMO in place, which by the way they said is still a few months away, even though they have a few potential candidates. So I assume Dr. Chan is still operating in both CEO and CMO roles.
The silver lining in the call is that the company is getting a lot more exposure from this coronavirus epidemic and has some potential opportunities should they get some contracts with the US government task force and from China Medical Systems and seems to be getting some return on investment direct sales force expansion.
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