Not being a Debbie Downer, but this is just an exercised option at 2.56...She would be nuts not to exercise the option since it is above water, Hopefully we have reason to celebrate one day
its a dosage compare, I think.
There is an article out today but I do not have subscription to read. Was wondering if any of you have access and can share?
im listening to the call now...They haven't said they wont seek legal recourse if the FDA comes back with unreasonable demands. They think the meeting is a positive step forward especially they initially denied a meeting. They "think" the agreement to meet is because of more data they sent to the FDA but don't know for sure.
AcelRx has been granted a General Advice meeting with the U.S. Food and Drug Administration (FDA) in early September to discuss the FDA's request for a clinical trial and the company's planned response to the Complete Response Letter (CRL) issued by the FDA for the New Drug Application (NDA) for Zalviso.
certainly puts in a bottom for this and gives it an equitable value. The EU first milestone itself represents 10% market cap...if zalviso gets any sign of life in US then the lid will blow off - thats a big IF though...best of luck good to see you around
whoever gave me a thumbs down is unrealistic - lol...im pretty sure i hold more shares than whoever that is...hope im wrong...hope for the best prepare for the worst...at this point, assuming fda wont budge, i would rather them find a good suitor and cash out
falcon - I agree . I think the bottom is here at 3.50-4.00 with arx04 and EU...however, i anticipate a negative reaction to the call when they advise FDA is not budging on the 750 person clinical trial. While the FDA staying the course is priced in and expected, I think the market will react negatively for the short term and then recover in this range. just my two cents...if we get an unlikely surprise with the FDA bending then we will get a huge jolt in the PPS.
That being said, if you watched L2 this week you have to think that the news wont be a surprise to the upside with zalviso
unfortunately I think the FIX is in for Acelrx and the FDA. The REMS option is a great one; however, I just dont think ZALVISO is going to get a good look again without a clinical trial - they are being punished for the approach with the FDA.
I think one is coming, but I dont think it will be below 3 if they do it soon. I have seen far worse bio pharma get better pricing...time shall tell. If they are doing their job they would figure out how to mitigate the FDA mess
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