JPwe have a good thing going on on this PIQforum.every now and...

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JujuM

1,328 Posts.

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05/01/23

08:50

Post #: 65537431
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Originally posted by JPGuru: ↑

Thanks, I had a look at some announcements and I can see from below that company is in contact with FDA since April 2021 and then FDA responded that 510(k) not available to PIQ so they should apply through "De NOVO" pathway and based on below announcement company supposed to submit for "De Novo" in Q1 2022 so before March 2022 ... but I can't find any announcement which says company has done such submission so what is stopping or stopped company to apply for "De Novo" pathway for last 14 months as below announcement came out on November 2021 (https://newswire.iguana2.com/af5f4d73c1a54a33/piq.asx/6A1064457/PIQ_FDA_advises_regulatory_pathway_for_PromarkerD_in_US) .. !

does anyone know why such a novel thing wasn't submitted for last 14 month for "De Novo" application ? As company made comment they will do submission so they should have come back to you all with explanation in last 14 month on why or when they doing it ? as it supposed to be by March 2022... !!... let me know if such submission was done and i missed it so i can go back and read more announcements !

This forum is to share opinion and not necessary agree to everything or sing la-la songs ... if you don't know answer then it's fine and if you know then share ... and if you don't want to share what you know then also fine but no need to agitate like kids who normally get agitated when you ask question about maths while they wanted to start eating candy .... in my opinion.. !

Now it would be good if someone knows what happened to FDA plans ? Also what happened to CLIA ?

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JP

we have a good thing going on on this PIQ
forum.

every now and again a numptie jumps in and starts stirring up the contributors with statements like la la songs etc etc etc.

there are no la la songs on here

please keep your opinion as your opinions, your questions as questions and don't make them personal by being adversarial

many thanks

PIQ Price at posting: $1.07 Sentiment: Hold Disclosure: Held
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Last 34.0¢		Change 0.000(0.00%)		Mkt cap ! $55.59M

Open	High	Low	Value	Volume
34.0¢	34.0¢	33.0¢	$16.1K	47.54K

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No.	Vol.	Price($)
5	60638	33.0¢

Sellers (Offers)

Price($)	Vol.	No.
34.0¢	11598	2

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No.	Vol.	Price($)
5	60638	0.330
2	20582	0.325
1	5656	0.320
2	21063	0.315
7	63669	0.300

Price($)	Vol.	No.
0.340	11598	2
0.345	29110	2
0.350	24893	3
0.355	2498	1
0.360	35000	1

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JPwe have a good thing going on on this PIQforum.every now and...

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