If this isn't a stock to short nothing is. They're either going to come out with a secondary offering in the next 30 days or someone with a brain will require them to release a "scholarly" paper not some news flash written by their marketing department or worst case the investment community will start taking profits to drive this puppy back down to $12-14 / share so they can ride it back up again over the next 6-9 months. If you're SHORT, just hang in there. It's just like investing as a LONG. Things take time to work. Any SHORT north of $17.50 is a safe bet for profit. $15.00 you'll be waiting a while and might not see too much cash flying your way.
Sentiment: Strong Sell
I admire you for having a clear vision of the future. I hope you act on your insight with conviction, and I hope it pays off for you. If not, don't worry, it's only money.. But there is no need to call Neurocrine a pig, unless you have proof of wrong-doing.
Interesting question. Most fast track NDAs or BLAs are for extreme cases of "unmet" need, which typically boils down to cancer or rare life threatening diseases or even currently under covered bacterial infections or virus. TD (like that of PD, MG, MS or SLE) is a terrible disease to be diagnosed with. Symptomology stinks, burden of disease is high and impact on HRQoL (and caregivers) amongst some of the worse. That being said, "Fast Track"... it will be up to NBIX and how their PII debrief meeting goes with the agency, plans for the 2 PIII studies and expectations. Fast Track requires data for review (that being PIII) which NBIX hasn't begun collecting. The better question is how many patients, sites and what will be the timeline for them to complete the 2 required PIII studies. How quickly can they enroll patients and what will FDA want to see w/r/t endpoints and their respective timelines. If they'll be okay with 8-12 weeks for primary and then maybe 12 weeks follow-up, that wouldn't be bad at all for NBIX.
I think NBIX would like to stay away from the 50mg dose for fear of efficacy short falls, but their right now probably going through the sub-analyses by dose to see if only 75mg or maybe 75mg and 50mg would be included in the PIII studies. You'd be surprised how often it comes down to the benefit / risk question of effecive dose vs. side effects. You need a safe drug but it's go to work too. I'll bet they go with both just to be sure to cover off on the minimum effective dose if possible.
I'm looking at this as an investor right now, not clinician. Just feel
the run up has been fast and a bit overdown. Profit taking and potential secondary (or fear there of) will bring it back down to earth. Then, I'm all for a LONG position in NBIX.
Others with similar strong product pipelines and nice science are SNTA and THLD. At least one if not both of those two stocks should see similar rocket like price movement before year's end.
Just my take.....
the longs are in this deep not the shorts. Shorts haven't even begun yet. You'll know it when they do start though. Downside risk is generally huge on these stocks. The pps is already in the red zone and begs to come down. If you're in at 9.00 or 10.00 great but if you bought in at 16.00 or higher good luck. Maybe it works out, or maybe this drops like a rock like so many others.