Week 10 it is Eqz, since we received this ANN on FDA pre-sub meeting & yes 100% right in your post. Thanks!
Promarker D is novel, there is nothing to compare it to that is already approved & on market, so this is why this meeting is so important to get it right which on FDA Approval pathway to pursue for approval, De Novo (novel) or 512K. This is a time that the FDA can recommend that we apply for Breakthrough Device Designation also (pre-submission).
This information is all available on FDA website, they make the rules & strict timeframes for their own assessment. Not us! So as a Company or shareholders doing research...
We have discussed all of this prior (with links) so not going to re-hash again apart from the important bits above.
Janssen (J&J) Ph2 data on Ph2 could drop any day now.
Nice close today & best wishes all. Makes a nice change to the usual ‘extreme’ rollercoaster on PIQ. I was thinking of you all at the Sydney Royal Easter Show on Saturday, Extreme rides.
GLTAH
PIQ Price at posting:
$1.30 Sentiment: Buy Disclosure: Held
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