"Prior to submitting a De Novo request to the FDA, we recommend you consider submitting a pre-submission to obtain feedback from the appropriate premarket review division." thats what the FDA say.
Once we receive feedback then FDA de novo can be prepared and submitted. Should take a further 6 months at least for the approval to go through? I think it will look like early 2021.
Also the Qtrly for March last year came out end of April, so we might be 2 weeks away from that.
PCK Price at posting:
11.0¢ Sentiment: Buy Disclosure: Held
