The CHMP recommendation should be this Friday or certainly on Nov 21. At times the CHMP recommendation/decision is the month after the oral arguments. We just have to wait and see.
The full post can be seen on Investor Hub's Orex's message boards, Yahoo is not allowing me to post more
Type 2 diabetes mellitus with at least 2 of the following:
Hypertension (controlled with or without pharmacotherapy at
Keep in mind the Light Study enrolled 9000 high risk patients:
=50 years of age (women) or =45 years of age (men)
Body mass index (BMI) =27 kg/m2 and =50 kg/m2
Waist circumference =88 cm (women) or =102 cm (men)
At increased risk of adverse cardiovascular outcomes:
Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following:
History of documented myocardial infarction 3 months prior to screening
History of coronary revascularization
History of carotid or peripheral revascularization
Angina with ischemic changes (resting ECG), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study
Ankle brachial index
More reasons Contrave will get a positive CHMP vote this Friday !
Michael Narachi bought 50,000 Orex shares on Sept 15, 2014, ONE day after submitting reply to CHMP 180 day questions. If that is not confidence, then I don't know what is.
Google: chmp agenda october 2014
See page 6 of 29 , 1.Oral explanations
Pre - authorisation procedure oral explanations
(EMEA/H/C/003687) , (naltrexone /bupropion), (indicated for the management of obesity)
List of Outstanding Issues adopted on 24.07.2014.
List of Questions adopted on 20.02.2014.
Possible Oral explanation
to be held
21 October 2014
Placebo caused 6 times risk of suicidal thoughts compared to Contrave ! - In Contrave trials One event of suicidal ideation in Contrave group (1/3239) and 3 patients in placebo (3/1515). This means that placebo effectively had more than 6 times the suicidal ideation compared to Contrave.
The warning is standard for all antidepressants
Quite possible, the stock is worth at least double vvus and arna if EMA approval, will jump big on Friday
One event of suicidal ideation in Contrave group (1/3239) and 3 patients in placebo (3/1515). This means that placebo effectively had more than 6 times the suicidal ideation compared to Contrave.
FDA approved Contrave did it not despite black box ? Besides do you know that Contave has 2 generic formulations bupropion and naltroxene which are already approved in EU for decades and used without any problems ? Besides black box is standard for any antidepressant, and despite that dozens of antidepressants are approved in EU, Further Contrave has no higher risk of suicide or suicidal ideation, in fact it was LESS than placebo in Contrave trials, so that will be a non-factor for EU. In phase 2b and 3 trials with Contrave, there were no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior in any treatment group compared to placebo. There were four events of suicidal ideation or behavior during this trial, one event (1/3239,
Crieteria for EU approval : 1. conducting a dedicated cardiovascular outcome study. The study population should mimic the target population and include a representative proportion of high-risk patients. The EMA recommends a composite endpoint of major cardiovascular events (MACE) : LIGHT study with Contrave was specifically designed with these factors in mind. At the end of 1 year in high risk obese patients including diabetics, patients with heart disease, smokers, etc there was no unacceptable increase cardiovascular risk. the LIGHT trial was the basis of FDA approval
2. At least 12 months of meta-analytical data, an analysis of medical literature and the absence of an increase in pre-clinical trials - Contrave showed no increased CV risk in original studies of 4000 patients, then in LIGHT trial of 9000 more patients at 12 months no significant increased cardiovascular increased risk was noted.
3. Weight loss medicines should show a neutral or beneficial effect on parameters associated with cardiovascular risk - Contrave showed reduction in HbAic, improved lipid profile. while HR and pulse was elevated compared to placebo it was in the initial 3 months, then it was not different from the base line at the end of one year.
4. adequate weight loss - Alli and Xenical are approved in Europe with lesser weigh loss compared to contrave, weight loss with contrave is not an issue per CHMP 180.
Hence main issue with Europe is the risk vs benefit, the LIGHT study has gone a along way to allay those concerns. that gives orex a high chance for EU approval. CHMP opinion will be this Friday, Oct 24
and what do you think the LIGHT study with contrave was all about ? Firstly initial contrave trials did not show any increased cardiovascular risk. Then they did a dedicated CV study called as LIGHT study, so try reading about it.
1. Light study at end of 1 year compromising of 9000 patients, did not show an elevated cardiovascular risk, it had high risk patients with h/o heart disease, smokers, diabetes, etc. all the reasons Contrave will get EU approval, it has met all the goal posts for Contrave approval