Pete - thank you kindly for sharing this info. Doesn't sound like this "Crl" is much work to clear, but still baffled how they got to this point. Perhaps they rushed the nda filing to meet their advice to the street and shareholders. I would have preferred to take the hit up front for 3 many delay rather than the shock as a Crl to the pps. Also, shocked this happened with the board of directors they have especially Adrian Adams. It's acelrx'so first rodeo as a company, but between some of mgmt and BOD it's not! Just amazing...
thanks pete...im still stuck on "Additional bench testing will be required"... implying there will be more work to come
maybe adrian adams will orchestrate a buyout like he has in the past and do us all a favor. Yeah Im a little lit right now but I do appreciate your input pete...
... "Additional bench testing will be required and human factors testing may be required to address certain items in the CRL. There were no requests to conduct additional human clinical studios"
Well, yes there is one thing.... "Additional bench testing will be required and human factors testing may be required to address certain items in the CRL. There were no requests to conduct additional human clinical studies. "
I think eventually. He was upfront all along that he would wait until PDUFA to hire anyone. I also think that this impacts commercial launch.. I guess the glass half full approach would say this gives them more time to prepare for a commercial launch heh...For sure, there are some hard lessons to learn on this mgmt tea. Up to this point, I had confidence in them but the fact they didn't handle this with a delay is troublesome.
First off - Congrats to the shorts. Although I don't care for the approach or tact at times, but I have to tip my hat and say you were right. The accumulating short interest and departing officers, mainly David Chung, was an ominous sign that I tried to discount. In the end, we now know why those things happened.
Future, Well now we have to say where do we go from here if you hold onto any long shares. I will sell some for a loss and trade here or elsewhere, while holding a core position. There is no question this will get hit for awhile, why wouldn't it? We are about a year away from decision time again with the US FDA. In the meantime, how does this impact the EU submission? Anyone care to share intelligent thoughts? I am not nearly as aware of their process as I am with the FDA. I have seen some speculate the EU is easier? If there is an approval date soon, that is an obvious catalyst. Another catalyst, is the submission of ARX04. So I wouldn't say this stock is a catastrophic loss at this point, albeit painful at this time. Hopefully management learned a lesson on dealing with the FDA. A simple delay could have prevented the CRL, although I am a bit surprised they missed the way to control the bleeding here especially with Adrian Adams heading the board of directors.
yeah, honestly this is the same management everyone has been touting the last two years, including me. Ummmm not so much now. Sadly, all the signs were there with the short accumulation and officers leaving. This information got out and that is a fact and its the retail folks that really got the shaft. Sigh...There is still hope for holders, but it goes without saying its going to be turbulent
Well, I don't necessarily want to give you credit bc I dont agree with everything you post. But I do want to say congrats on your earnings. Apparently some of what you said has merit and was right.
its a good point
where it closes it wont matter...now it is like putting money on red or black