Thank you Zeno9 for your comprehensive answer.I wonder if,...

First 52 Last

Share
Profile

Follow
patientvalue

59 Posts.

28

26/08/21

21:55

Post #: 55607822
Share

Originally posted by zeno9: ↑

Hi patientvalue

Yes NAN did make an announcement when they lodged the submission for trophon approval with the FDA.

The announcement was made on 13 May 2009 and indicated that the company had instructed its agent, Safis Solutions, to lodge a 510K application with the FDA for trophon approval. The NAN announcement stated that FDA expected to provide an initial review and feedback within 90 days of lodgement, and that was done by 10 July 2009, with NAN given 30 days to respond to FDA's initial review.

The NAN announcement also implied that the submission had been earlier delayed because of FDA requirements at the time for further extensive microbiological testing of the trophon device.

Notice of FDA approval for trophon was advised by NAN on 28 February 2011 - nearly 21 months later.

I would expect that the FDA approval process for the Nanosonics Coris endoscope cleaning product would be of a similar duration but given the amount of time this new product has been in development, it might be reasonable to also expect that the company is not too far away from being able to announce lodgement of a submission for Coris approval with the FDA.

The process for gaining CE Mark approval in Europe for Nanosonics Coris should be much quicker, as the timetable for trophon CE Mark was only 6 months from submission lodgement to application approval. So, it wouldn't surprise me if the European market for Coris gets a green light from the European regulator long before the FDA has finished its process. Furthermore, unlike with trophon which has required a raft of country specific guidelines in Europe on high level disinfection of ultrasound transducers before it generated any significant commercial interest, endoscope cleaning is already an integral and routine part of endoscope reprocessing in every jurisdiction - albeit a somewhat unreliable and cumbersome part of the process. Therefore, if the regulator CE Mark's Nanosonics Coris in Europe in a timely fashion, that should clear the way for a much quicker take-up of that product in Europe than has been the case in Europe with the take-up of Nanosonics trophon.

zeno9

Expand

Thank you Zeno9 for your comprehensive answer.

I wonder if, having gone through the long and rigorous FDA process once before, they have been able to foresee / anticipate the expectations of the FDA advance with the hope of shortening the process, even if by just a few months.

we shall see in due course.

once again, thank you Zeno and Michael for sharing your knowledge.

NAN Price at posting: $7.01 Sentiment: Hold Disclosure: Held
Upvote

0 Great analysis

Reply

Top Stories

PR1

Nanocap Pure Resources acquires Reedy Creek garnet project, WA

PRS

Prospech finds dynamite heavy REE grades from historic core in Finland

MKT

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

3DA

To make modern missiles, you need 3D Printing. And in that gold rush, Amaero is selling shovels

Trump is President Again: What Does This Mean for Crypto?

There are more pages in this discussion • 6 more messages in this thread...

First 52 Last

Add NAN (ASX) to my watchlist

(20min delay)
Last $3.28		Change 0.030(0.92%)		Mkt cap ! $995.0M

Open	High	Low	Value	Volume
$3.26	$3.34	$3.24	$677.6K	206.4K

Buyers (Bids)

No.	Vol.	Price($)
1	10000	$3.27

Sellers (Offers)

Price($)	Vol.	No.
$3.29	1049	1

View Market Depth

No.	Vol.	Price($)
1	10000	3.270
1	1049	3.260
2	1349	3.250
1	1049	3.240
1	2000	3.230

Price($)	Vol.	No.
3.290	1049	1
3.300	1049	1
3.310	1049	1
3.350	295	1
3.370	12888	2

Last trade - 16.10pm 11/11/2024 (20 minute delay)

NAN (ASX) Chart

Thank you Zeno9 for your comprehensive answer.I wonder if,...

Nanocap Pure Resources acquires Reedy Creek garnet project, WA

Prospech finds dynamite heavy REE grades from historic core in Finland

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

To make modern missiles, you need 3D Printing. And in that gold rush, Amaero is selling shovels

Trump is President Again: What Does This Mean for Crypto?

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Thank you Zeno9 for your comprehensive answer.I wonder if,...

Top Stories

Nanocap Pure Resources acquires Reedy Creek garnet project, WA

Prospech finds dynamite heavy REE grades from historic core in Finland

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

To make modern missiles, you need 3D Printing. And in that gold rush, Amaero is selling shovels

Trump is President Again: What Does This Mean for Crypto?

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News