I can completely understand all of the negativity towards MYX - a lot of it justified and evident in the current price. But, there is so much heat put on Myring like it's been a huge stuff up by the company. Yes they've had it since 2017 but the patent didn't expire on Merck's Nuvaring until first half 2018 and Mayne submitted their first attempt to FDA in around March 2018. They received the complete response letter at the end of 2018 requiring more bioequivalence data - this takes time. Yes, it would have been great to take less than a year to respond to the FDA, but there were additional studies that needed to be conducted and again, these take time. Meanwhile, all 3 other competitors also received complete response letters from the FDA. And only 1 of those competitors to date has had FDA approval. Teva and Dr Reddy's are still working on it and from public data it suggests that we are likely ahead of Dr Reddy's and possibly Teva too. This is a highly complex product. It's not your everyday walk in the park generic. Mayne haven't screwed the pooch on Myring, it's just the nature of the game. Re E4, it's a far less complex product by the sounds of it and I think if you were to look at a benchmark for Mayne's approval track records with NDA's (as opposed to generic ANDA's) then we should be looking at Tolsura - FDA approval on first submission. Everyone is only looking at the negative right now because that's where the share price is drawing our attention to. But if (yes I know, if) Mayne get approval for even 2 of the 3 big approvals pending over the next 6-8 months then the share price will be flying and the Teva deal will be long forgotten. Is it guaranteed? Of course not, but my view is the likelihood of approval, particularly for Myring, is quite high at this point. So I will stay in for at least the medium term, because at this price the upside potential is far greater than the downside. No doubt there will be a few choice responses to this and that's fine, but I'm happy to sit tight and let the next few months do the talking. I think we will see Myring approval by end-October and potentially the other 160M WH product before then (apparently it doesn't require site inspection).
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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) ? |
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