Summary: The FDA were totally unimpressed by false representations made by Mayne Pharma in a speaker deck presentation where Mayne made claims regarding the safety of this oral contraceptive vs competitors to which it was not entitled to do and also made little mention of the black box warnings on cardiovascular risk to some consumers. FDA requested that Mayne withdraws the claims or the product.
Mayne responded by withdrawing the presentation and this was accepted by the FDA in June. This should have put an end to this situation but obviously Cosette believes that this is a MAC event and perhaps (I have no evidence for this) Mayne made representations to Cosette during due diligence discussions which promoted the better safety of Nexstellis vs competitors.
What has happened to Nexstellis sales since the new marketing started in Q4? The QoQ growth in Q4 of 13,000 new subscribers was the best QoQ (in number terms) since Nexstellis began to be marketed. Whether this can be attributed to the now withdrawn speaker deck or other sales and marketing initiatives is undetermined but some research into Google searches for Nexstellis shows that the product maybe entering a new growth phase. Let's wait and see what the numbers Q1 FY26 look like.
MYX Price at posting:
$4.51 Sentiment: Buy Disclosure: Held
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