Ann: 2024 Full Year Results Investor Presentation, page-17

First 17 Last

Share
Profile

Follow
Michaelirish

24,132 Posts.

412

27/08/24

15:03

Post #: 75397143
Share

Originally posted by zeno9: ↑

Hi Michael

I thought the JP Morgan analyst was simply trying to ascertain how much of a delay the questions from FDA, the subsequent responses from Nanosonics, and then the consideration of those responses by FDA might add to the eventual approval process for Coris.

While Michael Kavanagh played a fairly straight bat, what he did say that provided some insight was that De Novo applications can take up to 12 months, which means in a worst case scenario, approval for Coris may not come about until the end of April 2025. As if to reinforce the plausibility of that scenario, Michael Kavanagh went on to say that the company was not expecting any revenue from Coris in FY25.

I thought Michael Kavanagh's above noted insights may have been a case of managing expectations to provide a bit of wriggle room for over-delivering later in the financial year, but his comment that all submissions to the FDA for device approval raise questions seemed just a bit simplistic to me. In that regard, I have no doubt that many submissions to the FDA generate questions which delay approval processes but I'm not sure why the FDA would have a policy objective of delivering decisions on De Novo applications within 5 months if there weren't some applications (albeit, possibly a small minority of applications) which sail through the process in that timeframe without follow up questions needing to be asked.

I think the underlying problem that arises for Coris is that it was accepted into the STEP program as a "novel and innovative" device warranting priority engagement by the FDA (second only in order of priority to what are considered by the FDA to be "breakthrough devices"). However, even though this was no doubt a good thing, the trade-off, as section III C of the STEP program guidance actually notes is that:

"FDA's past experience with priority review programs indicates that innovative products may raise additional scientific and regulatory issues that warrant more in depth review during FDA's review of the marketing submission. Therefore, the timeframe for review of the marketing submission may take longer for devices in STEP than for other less novel devices."

In any case, while I am revising my expectations for when Coris will be approved by the FDA, to some time early in CY25, I have to say that I'm pleased that all Coris costs for FY25, including regulatory engagement with FDA, marketing and other commercialisation activities and Coris inventory accumulation are all accounted for within the company's projected expenditure profile and don't appear to place a material burden on expected growth in profit for this financial year.

zeno9

Expand

zeno9 you are so charitable. When the JP Morgan question came , you could see Mr Kavanagh murmur here we go again. More material to base shorts on.
The way he asked it, oh you got QUESTIONS from the FDA? Dog whistle for shorters.
Mr Kavanagh is sick and tired of questions about the arrival of CORIS damaging the SP. So the hence the new emphasis on the profitability of T2 standalone

NAN Price at posting: $3.20 Sentiment: Buy Disclosure: Held
1 Upvote

0 Great analysis

Reply

Top Stories

HVN

Harvey Norman may appeal ASIC Federal Court case – the third lawsuit on its plate

RBA holds rates as ALP election campaigning kicks off – expect more political focus

Palladium's the newest geopolitical hot commodity. But ASX exposure is limited

MKT

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

JDO

Timing will be everything for 'smashing' Hot Stock tip Judo Capital Holdings

There are more pages in this discussion • 26 more messages in this thread...

First 17 Last

Add NAN (ASX) to my watchlist

(20min delay)
Last $3.17		Change 0.010(0.32%)		Mkt cap ! $961.6M

Open	High	Low	Value	Volume
$3.11	$3.19	$3.11	$481.9K	152.1K

Buyers (Bids)

No.	Vol.	Price($)
1	2072	$3.14

Sellers (Offers)

Price($)	Vol.	No.
$3.19	2072	1

View Market Depth

No.	Vol.	Price($)
1	2072	3.140
1	2072	3.130
2	1300	3.100
1	2345	3.090
1	2276	3.070

Price($)	Vol.	No.
3.190	2072	1
3.200	2402	2
3.220	2345	1
3.240	1036	2
3.250	1790	2

Last trade - 16.10pm 05/11/2024 (20 minute delay)

NAN (ASX) Chart

Ann: 2024 Full Year Results Investor Presentation, page-17

Harvey Norman may appeal ASIC Federal Court case – the third lawsuit on its plate

RBA holds rates as ALP election campaigning kicks off – expect more political focus

Palladium's the newest geopolitical hot commodity. But ASX exposure is limited

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

Timing will be everything for 'smashing' Hot Stock tip Judo Capital Holdings

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: 2024 Full Year Results Investor Presentation, page-17

Top Stories

Harvey Norman may appeal ASIC Federal Court case – the third lawsuit on its plate

RBA holds rates as ALP election campaigning kicks off – expect more political focus

Palladium's the newest geopolitical hot commodity. But ASX exposure is limited

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

Timing will be everything for 'smashing' Hot Stock tip Judo Capital Holdings

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News