i promise im not trying to be argumentative, but the formal FDA meeting is over 2 months away. And at that point, there is an OUTSIDE (very low) chance they are convinced a clinical trial isn't needed. More likely, they will discuss what the clinical trial will be designed as for what the FDA wants. Hopefully they want less than 100 participants, but still will take 6 months to establish, execute, and report that data. And then, there will have to be an NDA re-submission and wait another 6 months for a PDUFA. So honestly, we are looking about at what, 15-18 months, to get Zalviso approval in the US - if we are lucky? so if you are willing to wait 2 years, we will see 10 again but don't expect it overnight unless it is bought out...just my opinion...im a little negative right now so hopefully I will be more optimistic with more input from others.
thats awesome. glad some folks here in acrx can get some payback elsewhere...ziop is fading for now. as for our acrx holding, its painful...need some zalviso
ever get the feeling that the FDA is delaying and changing it up for other interests?
Im also sure they are kicking themselves for not doing a raise during the July 2014 runup when it was 10-13...if they did an additional raise then they would certainly be in better shape. Furthermore, If they would have took the bull by the horns last July and performed the right trials or analysis then, we would probably be close to a solid NDA...pennywise pound foolish with their time...
I just bought a nibble more at 3.70...I will just nibble here and there on the way down to scale in lower...if it goes up then i still "win"...best of luck guys and thanks for feedback
pentech - at this point might as well sell the company at 8 pps....i honestly think they are looking at the possibility of this...AA sold inspire after a failed clinical trial...
Are you guys still holding any core? I am certainly thinking of averaging down some. I just don't know if we are at a bottom yet and feel like we have some time before buying more with the face to face with FDA at least two months away. Small outside chance to get great news from that but very doubtful.
im thinking of averaging down some...but no need for a hurry so i will pick them up in pieces as it could go lower bc the next 2-3 months not going to be any news for zalviso
I thought 10 a couple of weeks ago but now that would be over 100% premium/....thats not going to happen.
In addition to reported direction, I guess I'm looking at another angle here of the "interim CEO". It is very possible that they are throwing in the towel with the current structure. Looking at possible 2 years until the first approved Zalviso sales coming in, so it is a no brainer tout costs to bare bone and march to approval - plus an equity raise is not optimum or even possible right now. To this end, perhaps they are looking to get this thing acquired at a small premium on the order of 25%-50% based on what they can get - perhaps more if they can find an interesting suitor. This is purely conjecture at this point but I think it is in the realm of possibility. Remember Adrian Adams orchestrated the sale of Inspire to Merck after the failed Clinical Trials of Inspire at a 26% premium in 2011 at $430M. That was after a failed clinical trial, so I think this could be higher - perhaps same ballpark price which is double the current share price.
which means once they stabilize things over the next year they will name a new CEO. Makes sense right now to have an "interim" ceo, cut costs, reboot basically...
Explanation of Responses:
1. The shares subject to the option vest as follows: 1/4 of the shares subject to the option vest on December 31, 2007 with the remaining shares
subject to the option vesting on an equal monthly basis over the following 36 months.
explains why it was 1.32 per share...she exercised the option...just hope she holds on to them! :)
Also, I wonder if some of the selling may have something to with share price under $5 now...like the Russell index perhaps...my small set of trading shares this week got stopped out at 4.08 lol,,,but bag holding long position
we may see ARX04 approved in the US before Zalviso...ARX02 and ARX03 will not progress as they are/were seek partners for those products. They are going at ZALVISO alone ; however, they may need to reconsider at this point