researcher, I am sure most realize you have multiple ID's, but you are really starting to creep me out with your Patches posts. If that was the goal, congrats.
Looks like since the CRL was announced they have added 2 weeks to meeting with FDA. Was hoping they had requested to meet with them. But 2 weeks in the scheme of things, nothing. Seems to be concern on the street that ACRX has been aggressive on when they will resubmit. Not sure where this has stemming, this team has met all previous deadlines (minus the miss on FDA approval).
Share are cheap here, imo.
I don't think its going to be a knee jerk scalp as many has predicted. I imagine there will be some opportunity to buy shares at lowest point during pre market. Expect some analysts updates over next 24 hours after company CC. Just like a sell on the news, there will be a cover on the news with the high short position. Price targets will not be adjusted lower. My only prediction is this will not sell off as hard as many are suggesting. I expect a close over 9. Uncertainty on FDA is out of the way. CRL on device only. Plenty of catalysts headed our way. And what is short case now? We know what FDA has said.
I appreciate some of this boards better posters educating me on the CRL class types. It appears we have type 1, but need certainty on this.
Its very common to have dialog with the FDA, and supplying information. But I don't understand what they haven't reviewed, maybe it was recent... who knows. They have been pretty transparent that they speak to the FDA regularly.
They said in the press release they are moving forward with the phase 3 clinical trials on ARX - 04 this year, so that is unchanged. Keep in mind they have milestone payments not factored in to their "break even" target. Another partner could also infuse some cash. Sales team, yes, I imagine they will not be there on Monday morning.
Thanks for clarification on that. Reading Class 1 criteria, it does align with what was posted in the PR. So there is a scenario where this gets approved in Q1 2015.
Actually this isn't accurate. They have Grunenthal that will provide payouts through milestones, that were not included to the breakeven status. But... I would expect another raise.
Its going to be 10 months, once the the NDA is accepted. Fast forward a year. Thankfully Grunenthal Group is engaged in the European approval process, and that should hit by end of 2nd half of 2015.
What is the point in responding to the FDA if they aren't going to review the response? (per the press release)
"We believe some of the requests have been addressed in amendments to the NDA that have been submitted prior to the receipt of the CRL but, as acknowledged by the FDA, have not been reviewed."
Playing out all scenarios, I could see King getting all employees together and making announcement (this would take a little bit). Phone calls out to our beloved European partner, legal review of the PR release prior to announcement. Maybe even having to track someone down on a Friday that might have left for day.... All these things, and the longer this drags out, I don't like. And this halt could be nothing related to FDA (slim chance). I am not a patient dude, and really don't like somebody making noise and leave us with no information.
If positive I know there are a lot of phone calls to make (there are a lot of phone calls to make if not positive). But once you have halted, you basically are calling a meeting of your shareholders. Lets go.
Looks like the aholes just went and grabbed a cold one to finish day out. Imo, reverse slam dunk from free throw line and made it look ez. I think everyone here should enjoy their weekend, locked and loaded here.
Been doing this all week. They peg it wherever they want and have endless shares. News release away from popping these guys in the mouth.