Thursday, February 17, 2022 5:43:07 AM
I believe the next steps for Positron to make going forward is the FDA submission of the new PET/CT machine. This will show the investment community that the company is moving forward in a timely manner. The FDA approval process should be somewhat quick as it's a machine and not a new trial of a drug which could take years. In general Medical devices seeking approval is at best a few months.
The 510K submission is just a submission for approval, if the company can complete the process in the next few months, I would believe that could relate for the company to have sales in calendar year 2022. This of course will propel the share price upwards to reflect a proper market capitalization for medical devices. It will be an interesting next few months, the positive is that the downside is limited and only the amount of upside is the unknown.
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