First and foremost, being in contention with the FDA is never a good thing for a biotechnology company. When the FDA has such a negative view of a New Drug Application early on, there’s a strong chance that the regulatory agency will reject the drug.
It’s worth mentioning that in the data released by the company, it seemed as though Twirla was a positive treatment with tremendous benefit as a contraceptive patch. However, the FDA seems to have found holes in the data. We will find out more specific information regard to what these holes or concerns are later, but that’s strike 2.
One thing that we know is that AGRX submitted a plan to get around potential risks by putting a label warning, limiting the drug to healthy consumers in terms of weight and BMI. However, the FDA seems to have rejected this, suggesting that the FDA may have found safety concerns in healthy consumers as well.
All in all, this news is bad as Twirla is the company’s ace in the hole. Without the drug, AGRX is back to the drawing board and investors are back to a very expensive waiting game.
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