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Down 75%, to just over a buck
Why it's not like we failed a trial...
ok, while this may seem sophomoric, I have to agree. It would be manifestly cruel, to name the trial this, if you had any doubt that the trial wasnt going to have a high expectation of being a success especially as the target group is young girls. Of course IMO
All Chris Sale references are to be commended
I know a ton about Brock....but then again I was born in 58. Brock and Gibson beat my Sox in 67.
I love prunes!
Why the sudden movement?
Why is the volume so high today? Thanks. Just stepped off a long flight trying to catch up...
Thanks Xena.
Of course I choose YOUR response as being most germane.
strong opening gambit 1,600 shares at 2.8199. wonder what this portends?
of course Im aware that certain parties will say nothing, and certain parties will say something...
So do I :)
Thanks Catt, hardest and best thing I have ever done
About to hit 16, wonder if there is any news anywhere buellar?
You are very lucky. I'm 33 years clean. Really think at some point this thing is going to save a lot of lives and also make. Us a lot of money.
Saw that! Things are picking up Cat!
Opiant Pharmaceuticals (NASDAQ:OPNT): Q2 EPS of $0.31 may not be comparable to consensus of -$0.55.
Revenue of $6.78M (+115.2% Y/Y) beats by $2.77M.
DBV Technologies Submits Biologics License Application to U.S. Food and Drug Administration for Viaskin Peanut for the Treatment of Peanut Allergy
PRESS RELEASE GlobeNewswire
Aug. 7, 2019, 04:05 PM
Montrouge, France, August 7, 2019
DBV Technologies Submits Biologics License Application to U.S. Food and Drug Administration for Viaskin Peanut for the Treatment of Peanut Allergy
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years. Viaskin Peanut is the Company’s lead product candidate based on epicutaneous immunotherapy (EPIT®). Viaskin is the Company’s proprietary, investigational platform that is designed to leverage the skin to activate the immune system and induce desensitization to allergens.
This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December 2018, when DBV voluntarily withdrew its prior BLA submission for Viaskin Peanut. The FDA did not cite concerns related to the clinical module of the BLA for Viaskin Peanut in December 2018.
“This is an important milestone for DBV, as we are one step closer towards potentially bringing Viaskin Peanut to patients.I want to thank the team for their dedication in working to address the FDA’s findings over the past few months. Everyone at DBV is highly committed to potentially addressing the significant unmet medical need facing peanut-allergic patients,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “We would also like to thank our investigators, clinical trial sites, as well as the children living with peanut allergy and their families for all of their help in the development of Viaskin Peanut. We look forward to working with the FDA throughout its review process.”
Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively. The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including, two Phase I studies, four Phase II studies and two Phase III studies. The two double-blind placebo-controlled Phase III trials, PEPITES and REALISE, studied patients aged 4 to 11 years for 12 months and 6 months, respectively, and were included in the submission. Additionally, supportive long-term data from the Company’s open-label Phase II program were also included in the submission.
I am also getting presentation hasnt started yet, could someone note the high lites please?
Bla submitted
Doom And Gloom! Lol.
Wishing you good health and a full recovery.
Actually he changed his Twitter name 3 years ago due to the heat he was taking. He is still very active on Twitter. Pm me if you want his new handle and yes he still is crapping on AVXL
Well Done Falconeer!
Because the pinning system which used to be absent of gaming is no longer so pristine sadly
Huge must mean small in Olde German
Retail shorts screwed? GREAT NEWS thansk Xena that is always a good thing.
I think it must have been a fat finger, 4 buys above the SP, then POOF silence. Someone trying to screw around for effect I guess..
Shares at 2.90 AH?? Fat Finger? News?
A Million syllables condensed down to a few....And not rocket science but stating the obvious.... Come the day the data is in, and AVXL hits a grannie out of the park, this stock is going to triple digits. Come the day the data is in, and this stock gets shut out, this will go to mere pennies, if.
So everyone enjoy this gorgeous summer day! Words and thoughts here do not impact the actual result of the trials, enjoy the gorgeous sweltering listering heat!
Bio always a treat to read your words. Wishing you a tremendous and stupendous recovery. Attitude and positive energy does help, so offering you all that we have in abundance.
My sincere question, have the bears lost their touch? As hard as they tried, they could not drive the stock down to RED today. Have they lost their edge? AAIC day is usually their day to feast? Tots and Players.
By any measure, today was a great day. Every AAIC day, AVXL gets FLUSHED and at times violently. Today? AVXL stayed Green. Amazing the shorters and fudsters failed at their only job, taking all new AVXLinfo and presenting it in the most hideous light.
Better luck next time folks!
Smart move. 3.40 incoming....IMO
Well done Xena thank you for your DD and valuable contributions to this forum. You stand tall amidst the flotsam and jetsom.
Someone please watch out for Adam F or Jeanette. If they post or comment SOON that is goodnews for AVXL IMO as they will try to put their thumb on the scale, He has me blocked on twitter so if anyone sees his screed pleaselet us know thanks.
So far this is the first time I have ever seen the PPS not Crash as the AAIC is released, low bar though to be sure....
Just hit 500,000 shares...
Fascinating watching the back and forth as many are furiously reading the PR and making their decisions. Now 3.14....up or down?
Ladies and Gentleman, place your bets.
NOBODY has ANY knowledge a priori on what will happen today.
The presentation today will either cause the stock to rise, to fall, or to do nothing.
Anything else asseverated is speculation without facts.
Good luck to all.
GAB I wish you and your wife a miraculous outcome. Please try to hang in there, miracles do happen, so why not you?
Watch it broach .50, then flush. If you were day trading this, good day to make some money...