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Journal Publication is a stand alone and not dependant on anything other than :
1.Co author sign off : tick
2.Journal peer reviews : awaiting
are you in the industry?
agreed , they know little more than the pneumonic , those who think differently really don`t understand the first thing about how it works ..
Viking , MM/algo are just trying to follow XBI but they`ll only throw a modest amount of cash at it ..
3.5 cents bid offer .....its gonna bounce ...
RSI 31 ... wait for it .... wait for it ....
THERMO ELECTRON LIMITED, THERMO FISHER SCIENTIFIC, FISHER BIOSERVICES DIVISION, UNIT 1, WOODSIDE, DUNMOW ROAD, BIRCHANGER, BISHOP'S STORTFORD, CM23 5RG, UNITED KINGDOM
Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 32390 in accordance with Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 30/11/2021, it is considered that it complies with
The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17 of the Human Medicines Regulations 2012 (as amended)
72 Hours from inspection to certification ...
Depends on the buyer , if the buyer is listed they’d be 99% likely just to issue debt ( subordinated bonds )
at probably < 2% coupon ..JNJ , Merck BMY all could all raise many many billions in about 72 hours
Last Man Standing
Over the last 8 years I have periodically posted a screen shot of the Bloomberg Pharma & Biotech Catalyst Calendar .
Its a colossal data engine for every single current trial from pre clinical to Ph4 and is the definitive go to place for all institutional investors.
Over the years there have been 3 or 4 other trials that appeared under the GBM search Ph 3 search .... but now there`s only one ...
Yep ..remember it well and at least 10 other mirages ...
The Lancet ....
..used to relase a Ph2 trial result....
The Lancet Psychiatry Publishes Results from ADVANCE Study Evaluating Pimavanserin Treatment for Negative Symptoms of Schizophrenia
- Pimavanserin as an adjunct to an antipsychotic showed significant improvements in the negative symptoms of schizophrenia vs. antipsychotic treatment alone
- Pimavanserin well-tolerated among study participants
Business Wire
SAN DIEGO -- December 1, 2021
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that The Lancet Psychiatry published results from the Phase 2 ADVANCE study. ADVANCE was an international, 26-week, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of adjunctive pimavanserin treatment in outpatients with moderate-to-severe predominant negative symptoms of schizophrenia who had achieved control of positive symptoms with their ongoing antipsychotic treatment.
ADVANCE met its primary endpoint, with significant improvement observed with pimavanserin for the change from baseline to week 26 on the Negative Symptoms Assessment-16 (NSA-16) total score, compared with placebo (-10.4 vs. -8.5; p=0.043). In a post hoc analysis, greater improvement in the NSA-16 total score compared to placebo was observed in the 53.8% of patients (n=107) who received the highest pimavanserin dose of 34 mg (-11.6 vs. -8.5; unadjusted p=0.0065).
“Negative symptoms of schizophrenia are associated with higher overall morbidity and decreased functioning, and there are no approved treatments,” said Dragana Bugarski-Kirola, M.D., MBA, MSci, Vice President, Clinical Development, Acadia Pharmaceuticals, GmbH. “These findings lend confidence in our continued evaluation of pimavanserin for the treatment of negative symptoms of schizophrenia. We look forward to sharing results of the ongoing, similarly-designed, Phase 3 ADVANCE-2 study, evaluating pimavanserin 34 mg in patients with predominant negative symptoms of schizophrenia.”
In the study, pimavanserin was well-tolerated with high completion rates of approximately 86% in both the pimavanserin and placebo treatment groups through 26 weeks and similar rates of adverse events between pimavanserin (39.8%) and placebo (35.1%). Additionally, no clinically significant differences in vital signs, weight, metabolic syndrome or extrapyramidal symptoms were observed in the pimavanserin group compared to placebo. Serious adverse events were reported in 2.0% of patients on pimavanserin and 0.5% of patients on placebo and discontinuations due to adverse events were also low, 5.0% for pimavanserin and 3.0% for placebo.
“The clinically and statistically significant improvement in negative symptoms of schizophrenia with pimavanserin as an adjunctive treatment with other antipsychotics, combined with the observed favorable tolerability profile, suggest pimavanserin may offer a promising approach in treating negative symptoms of schizophrenia, a severe and difficult condition to treat and significant area of unmet need for patients,” said Henry Nasrallah, M.D., study co-author, Professor-Emeritus, Psychiatry & Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.
The ADVANCE study is available here.
About ADVANCE
The Phase 2 ADVANCE study was a 26-week, randomized, double-blind, placebo-controlled, multi-center, international study designed to examine the efficacy and safety of pimavanserin in patients with schizophrenia who have predominant negative symptoms while on a stable background antipsychotic therapy. 403 patients were randomized to receive once-daily pimavanserin (n=201) or placebo (n=202) as an adjunct treatment to their ongoing antipsychotic in a flexible dosing regimen. The starting daily dose of 20 mg of pimavanserin at baseline could have been adjusted to 34 mg or 10 mg during the first eight weeks of treatment. 53.8% of patients who were randomized to receive pimavanserin completed the trial on 34 mg, 44.7% on 20 mg, and 1.5% on 10 mg. The primary endpoint of the study was the change from baseline to week 26 on the Negative Symptom Assessment-16 (NSA-16) total score.
Baseline characteristics were similar across two treatment arms. The most prevalent background antipsychotics in the study included risperidone (38.5%), aripiprazole (32.5%), and olanzapine (28.0%). The average age of patients in the study was 37.2 years.
About Schizophrenia and Negative Symptoms
According to the National Mental Health Institute, approximately one percent of the U.S. population develops schizophrenia during their lifetime.1 Schizophrenia is a chronic, debilitating and often progressive mental illness characterized by disturbances in thinking, emotional reaction, and behavior. These disturbances may include positive symptoms, such as hallucinations and delusions, and a range of negative symptoms, including loss of interest, emotional withdrawal, and cognitive disturbances.
Studies show that about 40 to 50 percent of schizophrenia patients suffer from predominant negative symptoms.2 While currently available antipsychotic treatments for schizophrenia target positive symptoms, most patients remain functionally impaired because of negative symptoms, cognitive deficits, and limited social function. Negative symptoms have been shown to impair patient outcomes, e.g., personal relationships, household and work performance and lower quality of life.3,4,5 Negative symptoms have also been shown to be associated with an increased likelihood of relapse and hospital admission, as well as a longer duration of hospital admissions.3,6
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in psychiatric and neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for treatment of negative symptoms of schizophrenia. In addition, Acadia is developing pimavanserin in other psychiatric and neuropsychiatric conditions.
About Acadia Pharmaceuticals
Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.
Important Safety Information and Indication for NUPLAZID®
The night is darkening round me
BY EMILY BRONTË
The night is darkening round me,
The wild winds coldly blow;
But a tyrant spell has bound me,
And I cannot, cannot go.
The giant trees are bending
Their bare boughs weighed with snow;
The storm is fast descending,
And yet I cannot go.
Clouds beyond clouds above me,
Wastes beyond wastes below;
But nothing drear can move me;
I will not, cannot go.
Correct KIPK ... `crashing` is a bit strong but right idea
I`m sure you were but I`m also sure you were forever telling extremely highly paid people that were in melt down because their screens had frozen how to turn their machines on and off !
All the best
` have you tried turning it off , then back on ` :)
NEJM Rapid Peer Review
Authors may request a Rapid Review of their manuscripts. NEJM generally replies to Rapid Review requests within three business days and an initial decision on publication will typically be reached within two weeks.
Those studies that are most often approved for a rapid peer review generally:
*Deal with urgent public health concerns TICK
*Have potential to dramatically change clinical practice or to affect mortality TICK
*Are timed to imminent meeting presentations DOUBLE TICK
Here ya go Flip ,
Peer review is a very tidy process indeed
https://www.nejm.org/doi/full/10.1056/NEJM200011163432009
Very good. Thanks Flip
You`ll do well out of that ...
...it traded .7277 today
Youll remember LP said ` the halt might not have been for bad reasons ` ... but a halts a halt and no one cared ...
Maybe GMP certification , whilst no real big deal getting awarded it for us would certainly impact momentum ..
I just checked the stack , there`s no bid for 80k in at .75 ..
Sukus ,
Maybe pop to your kitchen and take a pinch of salt...
So someone wants to buy 80k and puts a bid at 75 rather than take the offer at 77 .... mmmm not too sure about that..
60- 80% bounce WILL happen .. stay cool
RSI 25 ... wait for the bounce ...
...check my Thankgiving gift post earlier...
Yep scare mongers re South Africa variant ..
There have been about 16 2% drops in the DJIA this year , all of which have recovered and some...
We are already buying dips across all major index's .
DJIA currently 2.2% down ...it will bounce..
Lykiri, when did you have that email exchange ?
I`ve spoken to them on the phone 4 times now on the PI help line but every time get batted back with call the company and ask them...
Defo ...
Isnt Thanksgiving ,
secular ? we don`t celebrate it over here.
..I think David Baskin is related to Carol Baskin
1.25% Chance
2.35% Chance
3.0%
4.0%
as long as the company tell the exchange first data can come out anytime the company chooses including bank holidays.
So I envisage , journal notify the company they will publish at midnight on line, the company then call the exchange and say data release imminent , then the normal official templated ` end points ` PR will be released to Bloomberg etc prior to market open.
JUST BUY WHAT YOU CAN ASAP THEN HOLD YOU`RE BREATH AND TRY NOT TO KICK THE DOG IN THE MEANTIME.