Dude thanks for this...this also confirms what I posted in the other thread - if the size of the trial is increased from 250 to 750 for example, we are only talking about 2 additional quarter MAX...In my mind of a worst case scenario, NDA filed Q1 2017. Even if the smaller size is agreed upon, I still think they take their time and get this right. I have been here through all of the initial P3 trials (three of them), and I'm not scared of this timeline at all. I AM JUST GLAD WE ARE MOVING FORWARD WITH A PLAN - ALBEIT VERY CAUTIONARY!!! Im satisfied so far...
I guess I did not read it as entirely negative...the trial, no matter the size, I think should be completed by Q4 2016 - if not sooner. I agree with you that they aren't going to spit out numbers until they have all i's dotted and t's crossed based on the past. Remember even if a 750 person trial, these tests are completed in 1 day typically. Im looking for an earlier upgrade this year that had somewhat of a timeline, and I think its on par with what we should expect. also, i believe that number will be lower. Regardless of 250 or 750, I dont think it expands duration by 2 quarters at most
ive seen it all in biotech...while the cash infusion is good for getting the zalviso trial completed, they still need ramp up and marketing, I'm not saying it is probable, but it is possible.
the fact that Placebo is ruled out, that should reduce quite a bit. I would have to go back and look at the old trial results to see how many there were. Another good thing, they wont have to run THREE ph3 studies like abdominal, knee, and cant recall the third. still not all rosy, but not all terrible either.
did you call TIm recently?
this "150" statement is interesting but I can see no verification. Is this speculation on Roth's part or is it something mgmt chatted up as you suggested.
i thought they are requiring a 700 patient clinical trial, rather than 150. If it is 150, I am buying more shares...otherwise, I am staying the course with what's left of my position.
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