Hi Smashersoc. Apologies for not replying earlier.
Interesting comment, which raises many a consideration.
Obviously as we know to move the pps significantly we need significant volume the usual daily trading here normally does not attract such a thing. We could even say that news such as in this thread does not move the pps that much, I note the volume is not that much different from the daily average. I think we can put it down to the proof of the pudding is in the eaten. If we look back at the significant pps movement and well above average volume we have to look at significant events. In that respect we have the approval back in 2010, The infamous senate letter at the back end of May leading into early June 2011, where 22M+ shares traded in one day, then we have such events as the triple + wammy as we hit $6 on the first patent victories followed by Alleged Off-Label Marketing, Patent Woes And Other Issues May Spell Disaster For Avanir. Stock PPS Slumps on unfounded rumours. Jim Cramer reappears. Since then we have Cowen and the Baker Brothers purchase, noteably these were new share issues, which leads me to think no large volume of shares are available for large investors, well not at the present time anyways. Yes we have a high tute holding percentage at present most got in early doors and gradually increased if I recall correctly.
PS I did not include the EU approval at this time, however as stated in amongst the above the proof of the pudding is in the eating, personally I like the taster.
Hello Hondobud, Robert and Avnrinvestor.
Hope you are all keeping well and please excuse me for replying to you all at once.
Many thanks for your notes much appreciated, that one came out of the blue makes you wonder what else can spring out at us.
Getting late over here, I’m done for the day. Well I will be after watering the garden so dry down our end.
Enjoy your evening.
You are right I’m pleased as punch on hearing today’s news. Ok we have a way to go with it as yet. However these snippets help me to get an understating on many fronts, not limited to partnering values, it goes on and on. Fred I must admit I grow tired of watching, reading and more watching for developments. My reward today is that I can see some of the aspects we have discussed over the years are coming to the fore front. The last bit that would knock me off my feet would be a collaborated simultaneous USA/EMA application under the USA/EMA collaboration agreement. There are pilot schemes running at the present.
Time will tell if the drug can become multi indication. I still say we have more than a goods chance.
Once again thank you for the note very much appreciated.
Of course the wording below is music to our ears, perhaps more so than we first realise.
"The endorsement of this Phase II study by the division of Psychiatry Products at the FDA lends support for the expedited development path for AVP-786 and is allowing us to reference the extensive data generated during AVP-923 development programs.
I’m particularly pleased with this statement in respect of the EU those that have been here a while would have listened to me banging on about the EMA variation add on route to speed up approval for further indications. Type-II-variation and extension applications Why has XXXXX been approved The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, XXXXX has been shown to have comparable quality and to be bioequivalent to xxxxx
You may recall memantine had at least 6 variation submissions to the EMA all at once. As recently stated the EMA as far as I know have no CNS applications under review.
As the FDA appear to be accepting AVP -923 data for AVP786 I would go with the EMA would be no different
All the above IMO is relevant to other aspects such as partnering and the like.
Time will tell but I look upon this as significant.
Best regards to all.
No it was a little to far north for me, but it did make good viewing in the afternoon, pleased that it was not the walk in the park they were predicting.
This news bodes well indeed, not just for depression. I feel we have been handed a key.
Hi All by copying and pasting the wording at the foot of the page into your google browser you should be able to view the FDA documentation
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Note it is a relatively new document
Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics
Best regards .
I thought you would pick up on that.
This news and the wording from the press release has unlocked a lot of doors IMO today.
I noted your comments regarding the wording earlier I think I have the answer for you, just getting the post ready.
Very best to you Onlyfacts.
Good morning Outrage.
Excellent news for us.
Enjoy your day my friend.
PS Could not resist the Hooray there is some pun in that.
vanir Pharmaceuticals has added a news release to its Investor Relations website.
Title: Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder
Press Release date:July 21, 2014 9:15 AM
For a complete listing of our news releases, please click here
200 Patient Phase II Clinical Trial to Begin During Third Calendar Quarter of 2014
Second FDA Division Supports Expedited Development Path for AVP-786
Hello Razor Good to see you about.
We best clear the matter of the flask up first. Ill just let you know that the temperature over here the last few days has been above 90F, now that is way above the norm for us. It is at these times that we seek to keep well hydrated. You will not be surprised to hear that the best thirst quencher known to us is tea in copious amounts. I would hazard a guess that this gives you an ample explanation of the where the flask is. Sarge will be pleased that it will be cooler over here next week.
On the need for new effective CNS drugs in the EU this remains a hot topic in the EU health systems. The UK government over the last year or so and of late have made grants available to assist in this area. Yet the fact remains, at the present time not one new CNS drug is listed on the EMA schedules for approval as far as I’m aware.
We have touched on the submission of a 2nd indication for N in the EU under the EMA variation process, that will be a good day for us.
Keep well my friend.
Prior to reading your weekly slot I was thinking I would take a look at the YOY comparison. Then I paused as I knew my old friend usually had a handle on that.
Well you did not disappoint, thanks for this weeks round up.
Yes we did have good news during the week this consisted of in the main record numbers and the Prism news. Those two apart, I think the news neuronrancher bought to the table was more than welcome. I can’t emphasize enough how good it is to see news in respect of potential further indications, needless to say I’m looking forward to the agitation news.
By the way they are all patiently waiting for N over here. On all the forums I read, I have not come across any real moaning about the delay it is if they fully understand. I still have in the back of my mind that, significant results to that 2nd indication could/will change the whole ball game and free matters up a bit all round.
Enjoy your weekend.
Very best regards
Hello Neuronrancher thank you very much for bringing this to the boards attention.
I have taken the liberty to copy and paste your whole post to the Multi indication thread. As far as I recall, it is the first information on any kind of study I have seen regarding bipolar.
Whilst writing a note to onlyfacts regarding your post Oct 26, 2012 extract below
Study of NMDA Antagonists and Neuropathic Pain (DM vs. Memantine after Ketamine "cure", no Q added)
Dextromethorphan for Diabetic Macular Edema
Placebo Controlled Trial of Dextromethorphan in Rett Syndrome (PCTDMRTT)
Dextromethorphan Combine With Amlodipine Treatment in Patients With Hypertension (DMTA07)
Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
Add-on Dextromethorphan in Bipolar Disorders (DM).
Once again Neuronrancher thank you very much certainly is great to know this aspect has moved along.
Very best regards
Thanks you neuronrancher
neuronrancher• Jul 18, 2014 11:08 AM
bipolar II and bipolar NOS
The utility of the combination of dextromethorphan and quinidine in the treatment of bipolar II and bipolar NOS.
Kelly TF, Lieberman DZ.
J Affect Disord. 2014 Jun 2;167C:333-335. doi: 10.1016/j.jad.2014.05.050.
Sentiment: Strong Buy
Dextromethorphan is an over-the-counter antitussive agent that may be a rapidly acting treatment for bipolar depression. Like ketamine, it is an NMDA receptor antagonist.
We conducted a retrospective chart review of depressed patients with treatment resistant bipolar II or bipolar NOS disorder who were treated with the combination of dextromethorphan 20mg and quinidine 10mg (DMQ). One pill of DMQ taken once or twice a day was added to participants׳ drug regimen. No changes were made to the pre-existing drug regimen during the course of treatment with DMQ. The primary outcome measure was the Clinical Global Impression-Improvement (CGI-I) score after 90 days of treatment.
Seventy-seven participants met the inclusion criteria. All had been experiencing depressive symptoms for at least two years, and the mean number of failed medication trials was 21.2. The average CGI-I score at day 90 was 1.66 (1=slightly improved, 2=much improved). Some patients reported improvement within 1-2 days of starting DMQ. Nineteen patients discontinued treatment due to adverse effects, chiefly nausea.
Because this was a retrospective chart review with no control group, conclusions about causation cannot be made. Nevertheless, the duration of depressive symptoms prior to starting DMQ makes spontaneous recovery less likely.
DMQ, an NMDA antagonist, may be effective in the treatment of bipolar depression. Because its putative mechanism does not depend on the monoaminergic system, it may be appropriate for patients who have not responded to other medications. Unlike ketamine, DMQ does not require IV administration
Thank you so much for the numbers and the additional information.
Have a great weekend.
I will go along with that, you may know I have kept a record of the short position starting from the first short report before approval. On the 10/29/2010 there were 12,879,047 shares short with a pps close at $2.42 The next short report 11/15/2010 there were 14,838,658 shares short at $4.76 one could say that the short postions held pre approval got caught out, however I very much doubt that, I know you would probably agree. With the high volume at the time there was plenty of scope for them to tidy up.
From more recent records you can see what you are saying and once again I can go along with it. They could easily have done it again by the number of shares short and volume.
Hi oppup - Hope all is well.
As you know and mention we have been through many ups and down since the dark days when we were sat here at 23 cents. Needless to say we shall see more. However the fact remains we are way up from those dark days where as we were constantly reminded of the threat of delisting at the time.
For those that are interested in the technical aspects please find below a link to the AAIC video highlights to date. Further videos will probably be published in due course.
Needless to say a whole host of videos can be selected on the right side of the screen
Not sure if this has been posted before, but here is some additional information that may be of interest. Presenatation and speakers names extracted from the conference web site.
Prevalence and Correlates of Pseudobulbar Affect (PBA) Symptoms in Nursing Home Residents
11:45am - 2:15pm
Wed, Jul 16
Presentation Ref P4-336
Speaker for Avanir Charles Yonan
Director of Medical Affairs at Avanir responsibility to provide strategic vision, leadership, and scientific expertise for Avanir’s health outcomes function to meet internal and external customer needs. External does that mean outside the US my interpretation is it does so Charles appears well deployed.
Avanir Pharmaceuticals, Inc.
Charles Yonan Avanir Pharmaceuticals, Inc
Kevin Foley Michigan State Univeristy, College of Human Medicine , East Lansing, Michigan
R. Tamara Konetzka University of Chicago , Chicago, Illinois, United States
Others mentioned representing Avanir
Fred Ledon Avanir. I think he was the former Senior Clinical Study Manager at Allergan
Paul Shin Executive Director, Clinical Research, R&D at Avanir Pharmaceuticals
Regards to all.