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Fly News Breaks for May 23, 2017
TXMD
May 23, 2017 | 09:41 EDT
Stifel analyst Annabel Samimy says TherapeuticsMD's Type A meeting with the FDA to discuss last month's Complete Response Letter is scheduled for June 14. The analyst sees two likely scenarios from the meeting. The first has TherapeuticsMD seeking class labeling with a Phase 4 post-marketing study to eventually amend the label. And the second has the company seeking an appeal should FDA hold firm in the 12-month safety requirement to justify a differentiated label. Samimy is "convinced" that TX-004HR remains approvable and she keeps a Buy rating on the shares with a $20 price target.
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