VERY large bids WERE (now gone) at 3.87, 3.78, 3.77...large asks at 4.20 4.25 4.30 4.45 and 4.50...they were quite large on both sides of the previous mentioned levels, however, certainly more on the ASK, my thoughts and bet is that we are going to see a financing now since they at least have EU opinion, perhaps? or pending filing about the FDA and trial to come.
yes - if you look down in the details for Sponsors and Collaborators:
AcelRx Pharmaceuticals, Inc.
U.S. Army Medical Research and Materiel Command
So it is ARX04
yes its a mess...how much money is wasted and not to mention lives because of their corruption
still - not surprising that this is rd today after green..Saw this fade coming a mile away. The traders on this stock, in which I used to be, sold high 4's and 5 which is the smart short term move. unfortunately, my open shares now have to stay here for a bit. While the PPS action today isn't glamorous, I am happy that we now have SOMETHING tangible and material to sink our teeth into with this - which is key for biotech. This will keep up us valid for awhile and nothing can take it from us unless EU yanks off market or something
""We appreciate the collaborative approach of the CHMP and look forward to continued collaboration with EMA to complete the regulatory process."" - I totally agree that the CHMP sets a company up for success if yhe science backs it up, unlike our FDA process over here. Very unfortunate - how many drugs never reach the market for those that need it because of the "muddy" waters (and political) process of the FDA. Look, I know that world will be ok without Zalviso and pain meds, but this happens in other areas where patients need help.
REsearcher and Jim - "The device is approved already" - I assume you mean they received the CE mark for the device. Do you think the new changes to the device is a concern, or they just roll with the old framework? I am basing this off of Roth's statement that the FDA wanted a new clinical trial due to the significant changes to the device..just curious to your thoughts
one other 6th possibility, it could be Alta partners unloading shares. Remember they reported and sold shares recently to get them under the percentage threshold where they dont have to file in the future, I would take this angle as well...Just better hope it isnt option 1,2 or 5 in my original post.
i appreciate the positive attitude, Adam. However, I have been around this stock way too long and seen too many things and ignored warnings in the past. I still own a considerable amount and hope you are right; however, my guy tells me something isnt right. Stock doesnt lose 8% in 30 minutes.
yeah that isn't good...here's my guesses:
1) the "informal discussions" came back as no dice and will be a formal update soon - too bad someone already knows apparently
2) EU something has changed - perhaps app withdraw?
3) Financing coming (I will take that)
4) op ex games? - doubtful
5) officer movement? oy let's hope not...
I'm pretty pessimistic with this...earlier today i thought cool we will get a little run up before EOM EU, but that drop today tells you something bad is coming. Te last time we saw a sudden drop like that we got feedback the next day that the post crl meeting with the FDA didn't go well...
I sold half to take on some losses vs other gains...who know, i agree with stock lurker, something not right. either way im half right.
correction - longer than 7 months, but more like 1 year to get the data, consolidate it with the other two studies and then submit to FDA
I see a lot of speculation around the timing of a potential NEW phase 3 trial for Zalviso in the u.s. Roth says that they could expect a new Ph 3 trial could be completed by the end of next year. Pentech argues that it is not possible for the Ph3 trial to be complete in that short amount of time - fair argument but I wanted to post one benchmark from the last trial. If you are truly LONG and have been here as long as I have, you will recall that ACRX performed THREE phase 3 studies (knee replacement, abdominal post op, and another I dont recall). I know the 3rd Ph 3 study was Knee Replacement with a size of 400. They started the dosing 8/23/2012 and planned for the actual NDA application third quarter 2013 - so that was around 7 months from the last study until the NDA submission? I do not recall the actual dates and will do more DD later, but getting this from their old PR.
SO the difference is trial size obviously, going from 400 to 700. What else isn't clear, is the design of a "new phase 3 clinical study"...Will it contain 3 separate studies again? Does the 700 consider all 3 studies?
I dont know yet...I dont think a year for 700 patients is that big of a challenge since the study of results only takes 2-3 days here...we are talking pain relief, not cancer research. The obvious challenge in my eyes is the COST...
I just went over to the CHMP site and viewed the stats...yes 44 approvals, 2 not approved, and I think 4 or 5 app withdrawals. Interested to see the stats on pain submissions...looking further but please share if you have them
am I reading this correctly? 95% positives ?? I admit that I am nervous with EU approval just because I am gun shy at this point with too many hits. But 95% CHMP opinions should bode well? let me know what your thoughts are here