The top will blow off on this one IF ....If the FDA accepts the submitted protocols and confirming no further human testing is in a new phase 3 trial...That is the only factor and risk keeping this pinned here in the 5.50 7.20 range.
pre-approval maybe...but if this ever gets an approved product I think it is certainly in the cards if you look at the players on the BOD
sorry if I offended :) no, I am who I am ...certainly not Patches or Patchen, whom has moved on to greener patches i suppose
should be fun! lots of opportunity for upside, and yes downside if they delay filing again. But I think we will be ok...GL
yes should be real soon...prior to march 31 is the guided re-submission so we aren't too far off from that catalyst assuming all goes well. Also, I am waiting on to see the new CEO is. The caliber of this hire is very important. We are also getting close to EU catalysts with zalviso and ARX04 of course here in the US
I dont see anything...not even SEC filing..Meh,,,this thing can certainly go down "short term" with year end selling and pending re-file..."long term", if you call a year a long time, there are a few catalysts that can propel this higher, and some of them dont rely on Zalviso. Stinks for now but oh well...happy holidays to all
furthermore, this company cannot endure any more officer turnover. Therefore, prudent to entice them to stay even after the CRL faceplant in july
hey Pen...the regulatory person was left out. and obviously Richard King was left out. Another somewhat "positive" around the grants is that they have a vesting schedule:
(also look at # 3) - and no I am not blindly defending it either Pen...
1. Issued pursuant to the 2011 Equity Incentive Plan.
2. The shares subject to the option vest as follows: 25% of the shares subject to the option vest on the 12 month anniversary of the Vesting
Commencement Date (December 2, 2014) and the remaining shares subject to the option vest on an equal monthly basis over the following 36
3. The shares have double-trigger acceleration on a change of control
Hey Researcher! BTW I am still here and have be meaning to reply to your question asking if any longs were still here :) I have just been real busy and not listening to a lot of the interim noise, but watching carefully. That being said, I investigated these this morning and glad to see that there is a vesting schedule into 2024 rather than a lot of dumping to execs as can be witnessed with many bio techs. To me, this tells me the board is telling mgmt to get this right and you will be rewarded. I like it...I did not notice those two omitted, but I don't really think it is telling an imminent issue with those guys.
I think its comical and short sighted that everyone is so focused on the risk of Zalviso and its submission. The ARX04 catalysts are worth a lot of money and even partnering with the DOD. Also, Acelrx is able to leverage previous ARX01 trials thus reducing the number of participants in the ARX04 ph3. No device with ARX04!
Hey Researcher - I haven't had the opportunity to listen to the London webinar. But my comments are related to the fact that we still have to hear back from the FDA that the Human Factors Study that ACRX has proposed are acceptable. We are approaching that window now of when we should have heard back from the FDA. The primary reason the they delayed the new submission is that they wanted that guidance to ensure they have everything they need this time. A couple of positive catalysts are on the way -
see some interesting movements today...GLTA---
missing tablets is an issue - that can't be denied or we would had approval last July man...DISCLOSURE I AM LONG WITH MANY SHARES
many block levels in the mid 6's - I haven't seen this in a while - hope you covered. Someone mentioned last week that Kings departure was semi-orchestrated for one last shot at covering - got to say you may have been spot on
I am not saying that Pentech is right, but there is still risk that the FDA will require clinical trials to account for the missing tablets. I do think, however, Acelrx will be able to satisfy the FDA with proposed IFU and Human Factors study. Even if you assume worst case scenario that a new Zalviso trial is required, it is becoming abundantly clear that the real value is to price in ARX04 in which the DOD is going to fund! No device required for this one...They used to say ARX04 was the icing on the cake, but I think its the other way around now - Zalviso is the icing on the cake and ARX04 will be the defining moment and product
thanks DJBxr2 - you are correct..I have been following ACRX since the mid 3's and have been trading in and out for 2 yrs in addition to a large core holding. I can almost guarantee my large core holding is larger than Permit has in this. I just don't blindly pump just because I own the stock. I like to have discussions and see both sides. And as for this post, all I did was quote what the Roth analyst said. thanks