@Raj143
In Mithra update from 2 April 2020.
"In the letter, Mayne has been requested to provide additional data to support the application. This additional data is not normally requested for generic products. Mithra is not concerned by the additional queries and expect to have the necessary data to be able to answer the FDA before year-end."
Based on the wording it seems that it is Mithra that needs to compile additional data for FDA.
Well seems that they completely missed that prediction for whatever reasons.
Mithra full year report 20 April 2021.
"
In 2020, Mithra launched its contraceptive vaginal ring Myring® in several European countries: in Germany (April), the largest European market and the second largest in the world, in Italy , fourth largest market in the world, as well as in Austria, Belgium (Feb), Denmark and the Netherlands.
....
The approval of the American regulatory authorities is awaited for the end of 2021-beginning of 2022, for commercialization in the United States by Mayne Pharma.
....
For the Complex Therapeutics, Mithra launched Myring® in Europe (Belgium, Luxembourg, Czech Republic and Germany) and is currently compiling the additional data requested by the FDA for the US launch.
.....
"
I could not find any performance related data on any of the other markets where Myring has already launched.
Companies like Farmitalia (Italy), Hormosan (Germany) is not publishing these results....
Curiously, Farmitalia is ultimately owned by Pfizer.
Myring has not launched anywhere in the world before EluRyng even with different regulatory authorities and partners.
Amneal which launched their EluRyng in Dec 2019 already reported in their 2020 Full year....US$ figures of course
"Generics net revenue was $1.3 billion for the year ended December 31, 2020, an increase of $34 million or 3% when comparedwith the same period in 2019. The year-over-year increase was primarily driven by 2019 and 2020 new product launches of$214 million, which included EluRyng and Sucralfate Oral Suspension"
So.....
Even though the current guidance is "end of 2021-beginning of 2022" I find it curious that their annual report in late April still contained "and is currently compiling the additional data requested by the FDA for the US launch."
Especially when there were rumours of submission in March....
What if we actually had a company clearly update us on a previously hyped product...the only thing in the Feb 2020 report was under key priorities.
"Successful launch of products pending at FDA (eg.gNUVARING)"
That is a misleading statement... makes it sound like in FEB 2020 Mayne/Mithra were waiting on the FDA???
As far as I know FDA is awaiting the addition information???
Mithra themselves where saying the additional information requested was out of the ordenary...without qualifying?
Very strange.
You have to wonder if someone in FDA was delaying things for benefit of Amneal..... OR if Mayne/Mithra messed up.
Or the most benign option is that their assessment is being done by a more rigourous group of people...rightly or wrongly.
(20min delay)