Macro: Mid October was the original FDA decision date for their drug. They gave it a complete response letter over manufacturing facility issues (see the steady drop in PPS). The FDA audited the AMAG facility, found defficiencies, so they did not approve and reported the defficiencies in what is called a "483". The PPS tanked in this time period as you can see.
It then immediately moved back up (in just a couple days) when it was revealed by the company that issues were minor, quickly repaired them, and re-submited the submission-LOL!. Nobody knew originally how serious the facility issues were? This happened quickly (in mid-November-see your chart for the PPS jujmp) and the FDA gave it a Class 1 (quick) re-review and a 12/30 decision date (mostly suggests again the issues were minor).
All thought this approval was imminent so I bought shares at this point (early/mid December). "Waited until what I thought actually might be the last throes of the process". NOooooo!
The FDA then did not meet that 12/30 date, the company says they have not heard of any response from the FDA to their facility resolutions and here we sit with a bouncing stock with all involved in limbo. Same old FDA crap!
The issues are minor but the current speculation is the FDA may have to go back to the plant and inspect the resolutions. Another point of speculation is that there was a manufacturing issue with the packaging and its unknown whether stability was re-initiated with a packaging resolution in October/November. Unfortunately the FDA takes weeks and months to schedule these visits and do what they should complete in days. The holidays and FDA vacations may have also played a scheduling role?
The PPS has held up well since, but as reported, I sold some because the longer this goes the more likely it can get dragged backwards by manipulating market makers. If this happens I can buy cheaper later with less exposure. I still have shares if it gets approved quickly!
I still believe in a very likely approval (no study issues or questions about whether its safe or works, and the drug label has already been negotiated), but the timeline was screwed up here by "you know who". They don't meet their metrics they set for themselves and likely did their facility inspection too close to the end of the review process and therefore the company got the 483 form at the end of the initial process.! I look for approval in the next 90 days, but the FDA is just that useless?
Net result-call it government red tape! Will the FDA just approve, or issue another review period (have been doing it either way)?
I am looking for re-entry under $30.00 or just take what I got and wait. Played it safe here-took some profit due to mistrust in this agency! They have become as reliable as FEMA! Don't get caught in a FDA flood! You'll drown!
Kutz 
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