Complete Response Letter (CRL) is an FDA denial. This is the worst outcome. They didn’t even get a preliminary DRL (Discipline Review Letter) to give them an opportunity to remedy any defect. This is not good news, it’s back to the drawing board, and MYX needs to give more information on the reasons given by the FDA for denying it - this bland level of disclosure here is not acceptable and simply wouldn’t fly if they were primary listed on a US exchange.
Ann: MAYNE PHARMA provides FDA update on generic NUVARING, page-4
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Last
$5.02 |
Change
0.020(0.40%) |
Mkt cap ! $407.8M | |||
| Open | High | Low | Value | Volume |
| $5.05 | $5.09 | $4.96 | $774.1K | 154.0K |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 3 | 3317 | $4.99 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $5.04 | 1291 | 1 |
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| Last trade - 16.10pm 25/06/2025 (20 minute delay) ? |
| MYX (ASX) Chart |