Hi Eqz,
Well that’s lovely to hear my detective work has cheered you, I felt the same way so happy to share mate
Clearly there is a lot of hard work & research going on behind the scenes & we know that the regulatory process & pathways are lengthy & tedious. Reading the application you can see just how important the research is & conference presentations.
What is interesting is that we do know PIQ are engaged in the regulatory process with the FDA, and there was a validated hold up with COVID-19 & FDA application.
PIQ did not ANN this application with TGA or MBS but we knew it was going to happen from the timelines presented (see screenshot) so what’s to say that we aren’t already on either De Novo or 518 pathway application already with FDA? IDK but it’s clear that they are not ANNing everything, & we may just get an ANN on Approvals?
GLTAH
Hi Eqz,Well that’s lovely to hear my detective work has cheered...
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