FDA approvals7 Dec 2021 10:45
Just had a thought, " why does POLX need to update the market, when they resubmit the paperwork", they don't coz we already know they have to submit.
I have a feeling the paperwork has been already submitted and now we are just waiting for the FDA approvals and we will get it just before the Christmas break, coz that will be near the 2 month mark as the company have previously stated, if this happens then the SP will rocket to 150 to 200p
"These issues are mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system. Polarean will work to address the issues identified by the FDA with a view to resubmitting the NDA and securing FDA approval as quickly as possible. Following resubmission of the NDA, it is expected that the FDA review period will take 2-6 months."
I could be totally wrong, but for once i am thinking outside the box,
"We remain confident in the safety and efficacy profile of hyperpolarised noble gas imaging and Polarean's ability to accomplish its goals."