I'll just keep it simple here.
PFUDA date set for May 7 Their lead drug THX-001 has been developed for women with VAG pain who normally take Progesterone. Its a common side effect of menopause in older women to have vag pain. This drug showed at full dose of 1mg a 300% decrease over placebo in vag pain and had 0 (yes that's zero) major effects like placebo did. There were typical pain or discomfort issues reported. Even at half dose .5mg, it showed a 125% decrease over placebo. They even ran the trial at .25 and .1 just to make the FDA happy.
Currently at $4.80 this had a huge drop from $9 when the FDA released a document on their NDA that said some "details" were not ok. They did not say what details and management still has no clue what these Details are.
There has been some heavy options trading on this the past month. It looks like there was a lot of calls sold for premium and then closed out after the drop for may Expiration. Today there has been some HEAVY put buying for may $5 expiration.
There is a huge 12k position at $7.50 may expiration calls, so this looks like investors are expecting a FDA approval.
I am looking for a $8 target price which I believe will be obtainable with FDA approval. There is speculation the FDA is looking for warning labels for the minor side effects which might delay the NDA and send this to $2.50 level.