Ferring can't get this product approved in the US. I know people who have first hand knowledge in working with the reproductive health people at the FDA and they are just awful. I would factor in a very difficult regulatory climate to anyone considering investing in a company that is banking on approval in the US for anything related to women's health that doesn't meet an unmet need
I don't think JNP necessarily falls into this category (except for their HRT approach perhaps), but I've been meaning to let you and the board know that there is a real problem at the DBRUP division of the FDA when it comes to my area of medicine
unfortunately the people that sometimes end up at FDA in certain fields are the washouts and not the best and brightest. I think it was masterlongevity who mentioned issues at certain divisions at FDA and this particular division falls into this category. KOLs are starting to get involved to see if they can knock some sense into the idiots at FDA so perhaps things will change soon, but i wouldn't hold my breath or put money (literally) on it. The FDA hasn't approved an IVF drug since endometrin 8 or so years ago despite numerous approvals in the EU (e.g. FSH-CTP, prog vaginal ring, etc.). We'll see how gonadotropin biosimilar fares. Ferring hasn't even been able to start a ph 3 for their recombinant FSH formulation while in the EU it is already wrapped up and up for approval
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