Yes winning! Can you believe it was actually 3 weeks tomorrow since that FDA ANN came out...I don’t know where time goes. WITHIN 10 weeks the ANN states (FDA timeframe) so it could be anytime within the next 7 weeks & I guess when the FDA are able to schedule it. Obviously it will be via ZOOM with COVID-19 restrictions on travel.
I will be holding my breath a bit on this one - as PIQ may be recommended to apply for Breakthrough Device Designation during this pre-submission meeting, that is if they haven’t done so already along with the pre-sub package already submitted. There is nothing with FDA clearance like PromarkerD, so to me that totally makes sense as we tick all the boxes on FDA criteria & this also allows for priority review for clearance.
A very encouraging sentence in the
ANN:
”Proteomics International will present the FDA with robust, peer reviewed clinical performance data demonstrating the effectiveness of the test, including a 3000 patient study undertaken with a global top 20 Pharmaceutical company”.
https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02338635-6A1019193?access_token=83ff96335c2d45a094df02a206a39ff4Not envisaging any issues here, it’s not like the FDA will say ‘you don’t have enough clinical evidence, go away & do more clinical trials’, because we already have multiple covering all the bases & the current one will be for
CDx status.
This is why the wait folks, keywords
ROBUST, PEER REVIEWED & this takes time & it’s been entirely worth it already.
I don’t believe that people are just dreaming about price targets >$2-3.00 on imminent news, or longer term predictions on uptake of an
ethically priced (so accessible) IVD @$USD 55 compared to ~$USD 900 for the closest comparison. Certainly not counting chickens before they hatch, but everything is pointing to a very positive reception for PIQ & PromarkerD with the FDA.
GLTAH
(20min delay)