The afternoon was great thank you, a tad on the hot side for me 86F.
With the afternoon now over it is cooling down thankfully.
You may find this a little odd other than N being available to those in need of the medication in Europe that is as far as it goes for me at present.
I fully understand the hopes for a EU/ROW partnership being immanent. Yes it would/should give the pps a boost on a level playing field, however IMO that would be the EU crown jewels gone with all that follows more or less with it. If they do partner soon I shall be pleased for all those that have wished for it and would hope that they have done well from it. For my self I would have to ponder on what may have been
I have said my bit on Europe on many occasions covering numerous aspects, I have tried to cover them all. After each post I have more or less thought there is no more to add, however as I keep a keen eye on developments and what has gone before something always grabs my attention while I’m searching around for pieces to our puzzle. I have another piece to my puzzle that I would like to share with you whether, it will fit its just a little early to tell.
Sorry to harp on cont…….
Thank you and Good Morning JD
"We commercially launched NUEDEXTA in the United States in February 2011 and we are currently assessing plans regarding the potential commercialization of NUEDEXTA in the European Union."
HI Crstimator – good to see you, I do hope you are keeping well.
If it was over this side of the pond a submission could be made under the EMA variation route. This method is commonly used for additional indications for a previously approved drug. Safety Data etc can be used from the original submission. In Nuedexta’s case the DM and Q will need to stay in the approved bands ie 30 -10 and 20-10 if it were to be say 45=10 further Data would be required. Of course Data would be required showing efficacy. There would be a few other matters such as patient groups for instance those that have not been included previously such as stroke in N’s case. In a nut shell the faster route is available over here, I have expectations on that in the future pending efficacy.
As for your side I have been asking a similar ? for years, the latest news I have gleaned being that from the new depression trial. In this case it appears they are permitting use of DMQ data as being bioquivelant to DDM/Q in part which should save significant time in respect of an FDA review.
I would not have answered your ? in full but I hope the above is of some use. I have a bucket full of notes on the subject matter and will go over the same, I’m sure I have some more concise information on your side procedures stored. In the event I find the relevant details I shall send them your way.
PS IMO the EMA variation additional indication route is a key issue that we will hear more about given efficacy for further indications.
Very best regards
Update from Neals - I do not think we have had an update for a long while if we have excuse me for posting again.
The Experimental Treatment of Bulbar Dysfunction in ALS
Nuedexta is a drug approved by the FDA for improving emotional lability in ALS and other disorders. Based on patient experience, a NEALS trial is seeking to evaluate whether this drug improves bulbar functions such as swallowing and speaking. The trial will enroll 60 participants.
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz, MD, MSc (Massachusetts General Hospital)
Richard A. Smith, MD (Center for Neurologic Study, La Jolla, CA)
First received: March 5, 2013
Last updated: July 28, 2014
Last verified: July 2014
California Pacific Medical Center
District of Columbia
Hi Sarge Trust you had a good weekend and thank you for last weeks round up and the musical selection. The latter I note bought out some of our distinguished message board members.
Have a great week.
Thank you Tom.
Nothing like telling it as it is.
PS Thanks for the previous records also, as you know it is important to keep a track record.
Thank you for the update. I knew you would provide them when available.
I would have though Ingalls & Snyder would have made a profit on that circa 1M.
Not to be sneezed at. I wonder if they act in a simarlar manner to some of the large investing groups over here, where as particular brokers in part have a free hand on the buying and selling and like to bank a profit for a bonus. Either way they have done well.
Look forward to the next bulletin
Very best regards.
No margin - thank you for your reply.
I can see where you are coming from as well as PFE’s position.
No doubt it is a fascinating time in the Pharma Industry, particularly in relation to novel drugs coming to the scene. From what I understand, treatment for CNS disorders is the 2nd largest in the drug sector and growing by the day as the population expands together with greater life expectancy.
I wonder if your good self or any other member of our message board community could advice me on, how many CNS drug applications are under review by the FDA. I can tell you at present time to the best of my knowledge that I’m not aware of one current submission for approval of a CNS drug that sits with the EMA.
As you will be aware for a lot of investor’s time in any given stock is relevant. Some may not want to hang about for what may seem an eternity, for what may be looked upon as a significant gain; others will take the 20% and move on.
I still say they made a bit of a hash by rushing the MS pain, may be to get some data out with partnering in mind. But then we still had the patent challenge hanging over us. We should have some good news later in the year ( Sarge if you tuned in why is it always around Halloween). Personally I do no want any partnering or sell off entertained until we know what we have including the value. I do not think we have conclusive evidence of the full picture yet.
Great to converse.
Hi Nomargin as you would expect the subject matter made big headlines at the time over here.
I caught glimpses of our government discussions on the matter. As the Pharma industry contributes significantly to our economy and exports, it may have had some bearing on taxes etc to have generated the interest of our politicians.
Good topic to keep an eye on.
Hope you are well.
Good morning Sarge - Thank you for the round up.
Is that right we are down three weeks in a row, must be if that is what you are saying.
There lies the secret and a clear demonstration that there are shillings to be made for the traders. Having said that you also elude to the light volume, to that effect the traders would be on the light side also.
Being a bit blunt, yeah I will keep the tin hat handy, the main reason being to protect ones Barnet from the BS dropping from above.
AVNR certainly have a lot going on in respect of trials. I noticed your good self and OFP mention the licence agreements during the week, high time we had some clarification on that front.
I had a quick look back at the pps ranges around the time of approval earlier today. It is a funny old game there we were with approval and not sold a pill and the pps more than doubles. If we were to get the same result for a further indication that would put us at around $12 based on where we are today.
Still a waiting game my friend, however we can agree on the duration being a lot shorter.
Enjoy the rest of your weekend.
Very best regards
Thanks for keeping us informed on this aspect look forward to receiving the updates.
All the very best
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.