It's interesting. I spoke to investor relations about 3 weeks ago re Nuvaring and they said the FDA has not been clear with them yet whether a site inspection is required. If the re-submission was completed late-Dec last year then 8 months approval timeframe (if no site inspection required) is basically now (late-Aug) and 10 months timeframe (if inspection is required) would be late October. It makes me wonder due to COVID limitations for site inspection - if a site inspection was required then surely FDA would have informed Mayne by now (and even by 3 weeks ago) to coordinate alternate arrangements (additional documentation, virtual inspection, EU regulatory partner inspection etc.), but it seemed they hadn't. So this potentially may mean that site inspection isn't required (they did an inspection in 2018 as part of the first application) and therefore there's a possibility we are only days away from approval...? Who knows...
- Forums
- ASX - By Stock
- Is MYX a bargain
MYX
mayne pharma group limited
Add to My Watchlist
0.20%
!
$5.08

It's interesting. I spoke to investor relations about 3...
Featured News
Add to My Watchlist
What is My Watchlist?
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
|
|||||
Last
$5.08 |
Change
0.010(0.20%) |
Mkt cap ! $412.7M |
Open | High | Low | Value | Volume |
$5.13 | $5.15 | $5.08 | $445.2K | 87.01K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 810 | $5.08 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$5.15 | 2033 | 2 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 810 | 5.080 |
2 | 3150 | 5.040 |
1 | 600 | 5.030 |
3 | 3000 | 5.000 |
1 | 10000 | 4.980 |
Price($) | Vol. | No. |
---|---|---|
5.150 | 2033 | 2 |
5.180 | 2396 | 2 |
5.190 | 5000 | 1 |
5.200 | 157 | 1 |
5.210 | 5000 | 1 |
Last trade - 16.10pm 27/06/2025 (20 minute delay) ? |
Featured News
MYX (ASX) Chart |
The Watchlist
PAR
PARADIGM BIOPHARMACEUTICALS LIMITED..
Paul Rennie, MD & Founder
Paul Rennie
MD & Founder
SPONSORED BY The Market Online