MYX mayne pharma group limited

It's interesting. I spoke to investor relations about 3...

  1. 525 Posts.
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    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...
 
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