Hello Onlyfacts – pleased that you got to see the post, I was certain you would have found it interesting.
Thank you for the additional information, I was a bit hesitant in bringing it to the board in the first instance, you will understand that. Regardless one can not deny that more and more links are apparent in this respect, some thing else for us to watch out for.
Very best regards.
Hi Horcents- first and foremost hope you are doing well I like to keep a track on you.
Then there is the tomatoes how is the crop doing. From what I hear the growers this side are having to do a lot of watering. Not that I grow any but there is a need to water the garden most nights. There we were back in early spring with water more than Knee deep, I had to dig a trench down the side of the house to assist getting the water away. Don’t worry it went into the river not the house just down the road.
Yes I can understand your thinking and one to keep an eye on. I liked the article for further reasons also. It is good to hear discussions on NMDA receptor agonists, as we know Nudexta has this mechnisim of action. Every time I see Ketermine it reminds me of OFP bringing it to the board a good while back.
Keep well and great to hear from you.
Interesting article for information.
In the first controlled study of this method of medication administration, investigators found the drug to be well-tolerated in patients with treatment-resistant major depressive disorder.
Researchers from the Icahn School of Medicine at Mount Sinai in New York have published their findings online in the peer-reviewed journal Biological Psychiatry.
Investigators found that among the 18 patients completing two treatment days with ketamine or saline, eight met response criteria to ketamine within 24 hours versus one on saline. Ketamine proved safe with minimal dissociative effects or changes in blood pressure.
The study randomized 20 patients with major depressive disorder to ketamine (a single 50 mg dose) or saline in a double-blind, crossover study.
Change in depression severity was measured using the Montgomery-Asberg Depression Rating Scale. Secondary outcomes included the durability of response, changes in self-reports of depression, anxiety, and the proportion of responders.
“One of the primary effects of ketamine in the brain is to block the NMDA [N-methyl-d-aspartate] glutamate receptor,” said James W. Murrough, M.D.
“There is an urgent clinical need for new treatments for depression with novel mechanisms of action. With further research and development, this could lay the groundwork for using NMDA targeted treatments for major depressive disorder.”
“We found intranasal ketamine to be well-tolerated with few side effects,” said psychiatrist and researcher Kyle Lapidus, M.D., Ph.D.
One of the most common NMDA receptor antagonists, ketamine is an FDA-approved anesthetic. It has been used in animals and humans for years. However, ketamine has also been a drug of abuse and can lead to untoward psychiatric or cognitive problems when misused.
My apologies OBHF for some strange reason the copy and paste will not stick yet the original is still there at the time of this post.
The post can be located in the Hooray thread as reply to Smashersoc FWIW.
I will try to copy and paste below the most relevant part to see it that will stick
“Since then we have Cowen and the Baker Brothers purchase, notably 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.”
Never mind the smile and wave, perhaps the old Winston Churchill signal may be more appropriate.
Once again my very best regards.
Hello OBHF trust all is well interesting date on the Incentive plan.
Avanir Pharmaceuticals, Inc. 2005 Equity Incentive Plan
Filed as Exhibit 10.21 to the predecessor California corporation’s Annual Report on Form 10-K, filed December 14, 2005
Recently I posted as below; the latter part of the paragraph IMO is some what relevant to what you have alerted us to in respect of the release of shares. Granted that in order to become a major CNS company this will inevitably mean a greater number of shares. In a way I was half expecting new shares to be issued (but not in this way) in the future, hopefully to go towards those possible new acquisitions which we were informed may happen.
You will know it would be a rare occasion that I would comment on the leader ship and will refrain from doing so at this time.
My very best regards
Copy post FWIW commencing Hi Smasherroc will not fit, posted as a reply
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