Hi Ralph I think you have diveded by 1.4 instead of x by 1.4 on the conversion rate.
Imo it can be done on pba alone, it depends on how.
I will run some numbers on the EU comparison spread sheet.
UK Populations census 2011
Hi Chico & orfe
(Avanir Pharmaceuticals Inc.) is the only EMA-approved PBA treatment. The financial impact of introducing Nuedexta to a national healthcare system, including Scotland, has never been formally estimated. METHODS An Excel® based cost-calculator was developed. Prevalence, epidemiology and mortality estimates for causative neurological conditions as well as PBA prevalence in those conditions were sourced from the literature. Unit costs (drugs, hospitalisation etc.) were taken from national databases and standard care treatment mix and resource use were derived from a US claims database. A range of market uptake rates were used with further sensitivity analyses undertaken. RESULTS The estimated cost of standard care in Scotland for PBA is circa £32.4 million annually (circa 22,500 patients). In year 1 following introduction, 67 patients are expected to receive Nuedexta, resulting in a cost increase by £0.1 million to £32.5 million. By year five, 836 patients are estimated to receive Nuedexta, resulting in a projected total annual cost of £34.6 million. Therefore the estimated annual budget impact of Nuedexta ranges from £0.15 million (year 1) to £1.88 million (year 5). The incremental cost per patient is £2,246. The model was sensitive to changes in uptake rates, cost of background therapy and PBA symptom severity. When patients with moderate to severe PBA symptoms receive treatment, the projected cumulative year 5 budget impact estimate is £7.56 million. CONCLUSIONS The estimated financial impact of introducing Nuedexta in Scotland is modest. Even if more patients are identified, the relatively small incremental cost per-patient of Nuedexta is unlikely to have a major impact on the Scottish NHS.
Hello Mr T
Thank you very much for your kind words, they are much appreciated.
I read the board for what could have been about two years before making my first post I was a bit nervous about doing so, coming from this side of the pond. Wish I had done so two years prior to that, your good self and many others have made me so welcome.
On several occasions over the years there have been discussions about an AVNR party, it would be a crying shame if that does not take place at some time in the future. I doubt if there is another board on Yahoo with such a fine collection of message board members as that we have here, especially the old timers.
My very best regards.
Just in case our path’s do not cross again, (I hope they do) thank you for all the pleasant communications over the years.
Wishing you and yours health and happiness.
You are so right my friend positive results in depression will raise the bar even higher, IMO AVNR know a considerable amount about the possibilities in this respect, the trial results will bring us some confirmation.
Excuse the pun but it really is mind boggling in respect of the permutations of treatments that may be available via one pill. This reminds me of the very first post
In the MS multi indication thread, from memory it ends with how cost effective a multi indication pill would be or some thing like that. The cost effective bit fits so well with our health system as well as many other EU countries.
We have talked about the pathways open to AVNR including the distribution systems (direct to hospitals) and many other aspects that could possibly come about.
Needless to say it is fantastic that we can see the possibilities gradually building up.
OBHF if you are tuned in my friend you often referred to KK being delighted mainly because of filling his pockets, well I’m also delighted and anticipating being over the moon.
Sarge I must dash off it is my lucky day. I’m off out to dinner with not one but two delightful lady’s.
Hi Razor trust all is well. Just to let you know, I have not forgot about replying to you
as stated. The thing is this particular watch is complex and to achieve the accuracy it warrants a little time putting it together.
Hi Sarge – Thank you for this weeks round up much appreciated.
On the EU front, a Year or two back I thought AVNR were some what between a rock and a hard post.
In reality I’m sure they have stuck to there game plan all along. You will recall the partnering debates that took place back then, beyond doubt we are pleased that they have held out to date and did not short change us.
I was particularly interested in Burgoo note regarding his visit to the AVNR HQ thank you Burgoo “Everyone is asking about Europe and in my interpretation, it is being deliberately stalled until Avanir has more to offer for a partnership there “ Those few words were very telling IMO.
Just a diity from my ongoing research into Multi indication drugs.
The logic is simple: more indications result in a larger number of potential patients and, consequently, greater revenue opportunities. Obviously this logic only works if there is unmet clinical need and efficacy is demonstrated in each indication, so the number of drugs approved for multiple indications is relatively small. But where multiple indications are approved, annual sales can be counted in billions of dollars.
Biosimilar approval for multiple indications, looking forward to that bit.
Enjoy the rest of the weekend.
Good morning All
Considering the process described in the first post of the thread (Please also refer to part 2 of the thread) IMO AVNR would have been hoping for plain sailing but more than likely pre-empting a little bit more work may be required due to the complexities of combination products.
Zacks Equity Research Article dated November 10, 2014 4:40 PM
Avanir Pharmaceuticals, Inc.’s shares were down 1.4% on news that the FDA has issued a disappointing preliminary feedback regarding the company’s new drug application for its Breath Powered intranasal delivery system, AVP-825. The company is looking to get AVP-825 approved for the treatment of migraine.
In its feedback, the FDA requested Avanir to conduct additional human factor testing on AVP-825 and optimize the product’s user interface. With the review under progress, the FDA may provide additional comments regarding the application. The review is expected to be completed by Nov 26, 2014.
Based on these developments, Avanir stated that the approval of AVP-825 will be delayed (previously expected by Nov 26, 2014).
Good morning Mr T & Frank
I was just going through the replies to Sarge’s Saturday report. As with most weeks
the report generates some interesting debates, this week being no different. In a moment I will bring forward a post which IMO is relevant to the situation. I’m sure AVNR would be aware of the complex nature of combination product approvals and have the situation in hand.
My very best regards to you both.
Thank you for note.
Ah yes the "Sr" that goes back a few years. We can put that that down to Sarge and a absent most valued old timer poster that we have not seen in a while Nirv. Years ago when the board was not busy at all, we talked amongst ourselves. I had just come back from Vacation in Italy, I can not remember which one of them thought Falconi sounded Italian so that is what they called me instead of Falcon. It must have been Nirv because I’m sure Sarge added the Sr, Sarge’s interpretation of Signore ( Sir) a few days later and it has stuck ever since.
Avere una piacevole serata ;-)
Thank you for the numbers, much appreciated.
Steady as we go, have a great weekend.
Hello Horcents - Yes I’m really well, thank you for asking and I do hope you are also.
You are right I’m really relaxed about the whole thing and extremely positive in respect of further indications. Not sure if you would have had time to look at it yet but I have just posted a link to Sarge. The link is a video of Dr Richard Smith explaining about N, you may have seen it before when I posted it a few years back.
Over the years I have gone over and over again such details as the Dr RS video, in fact countless other articles, amazingly many remain fresh in my mind. Not only I have I looked at what good things may happen, but I have also looked at what may not happen. Looking at the latter with an open honest view is just as important in my book, than just looking upon the good things, that way my expectations are balanced.
Sorry I keep repeating my self, however I’m so delighted with how N fits in to the systems over here, the last drug that used the system so well being Memantine. No need to tell your good self we have a ways to go yet, having said that with each day that passes we move ever nearer that 2nd indication, for me and more than likely your good self that is where more success is at.
Thank you for telling me about your Nephew’s proposal I’m pleased for them both.
I can fully understand your anguish when it comes to devoting time and affection to the family, I was going to say particularly the young ones but I know you would have the same thoughts for each and every one of them. Hope you do not mind me saying this l shall say it regardless, I also think that you do not have to prove anything to them I’m sure they would be aware.
My very best regards
Try and look at it this way, you will remember Gary Quack Quack PHhtttttt well that is one form of agitation.
At the other end of the scale we have the human brain but with a malfunction, the latter is the type of agitation we are talking about here.
For a refresher here is a review our founder explaining about our drug a bit better back in 2010 start off around 40 minutes in.
Oh by the way remove the xxx at the front of the link.
You are more than welcome, glad you found it of interest.
When AVNR submitted their EU application, the EMA asked some pertinent? If I recall correctly, I vaguely remember reading it in the EMA EPAR. I could not help but think the EMA had picked up on other indication use, well they were bound to as AVNR submitted every bit of data they had from relevant trials not just pba.
You will get me started!
Good of AVNR to be one of the main Sponsors along with the European Commission.
All the best.
Hello Bullseyecatnip. Good to hear from you, I’m pleased it was a help to you.
I would like to say so much that is relative to the thread, but I would be going on for ever and a day. Not a day goes by over here that you do not hear about such things be it on the radio TV the press the topic is every where, such is the enormity of the problem faced, which is growing with the ageing population.
One striking thing for me in relation to the pps is that unlike with the approval for pba we got a spike followed by a steady decline to 1.77 if memory serves me right. With just the clinical trial results being as good as they are we have sustained a good increase in the pps without a pill being sold for agitation (perhaps a little OL).
I have said it before and will say it again FWIW IMO I have not seen a drug that is so tailor made for the EU systems in decades.
Anti-psychotics have been a huge success in the past, a good reason for that being there was nothing else out there to use at the time. From just the videos you can see what is thought of these drugs in respect of there use……
As we know we have excellent trial results in agitation and we have a little way to go yet but I remain resolute IMO we have a multi indication drug right here. The latter being another story which major pharma’s want in on.
What a journey of intrigue and success my friend.
Very best regards
Please excuse me for posting this a bit late . Lots of things to consider and note not least the main Sponsors.
Also please watch the two videos. IMO having done so my self the same underlines what we have with N and goes some way to explain the value of the same. ( ps excuse the add video )
Alzheimer Europe held its 23rd Annual Conference in St. Julian's, Malta during 10-12 October 2013 with the motto "Living well in a dementia-friendly society". The conference featured over 110 speakers in plenary and parallel sessions, special symposia and workshops as well as poster presentations.
The 23rd Alzheimer Europe Conference in St. Julian's, Malta received funding from the European Union, in the framework of the Health Programme. Alzheimer Europe and the Malta Dementia Society gratefully acknowledge the additional support provided by foundations and companies.
Ministry of Finance, Malta
Partnering with European institutions
Alzheimer Europe will continue working towards this aim with all European institutions: the European Parliament, the European Commission and the Council of Ministers.
Preventing behavioural problems and avoiding the use of anti-psychotics
Behavioural and psychological symptoms of dementia: The elephant in the room?
Hope you find the above of interest and a special thanks for all the informative posts on the board from your side of the pond.
Hi Razor – I most certainly have read you’re well written Critical Juncture post and fully understand its contents.
Naturally I will be replying to you in the thread, the thing is you have cleverly covered so much of relevance in not so many words.