It might take upto Monday with huge news...If its negative company would have come out with PR today morning but that didnot happen.
Since the highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 October 2014 Meeting do not find any concern on RISK associated with CONTRAVE and therfore recommends to the CHMP.
with the PRAC's overall assessment of the risks analysis of its benefits and risks AND FURTHER advice CHMP meaning approval is on the way.
(PRAC) 6-9 October 2014 HIGHLIGHTS.
PRAC recommends strengthening the restrictions on the use of valproate in women and girls
PRAC review does not confirm increase in heart problems with testosterone medicines
PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig
1. PRAC Advice
[If questions on safety or the Specific Obligations are specifically raised by the PRAC, the following wording should be used:]
( , EMA/H/C/XXX/X/XX) could only be finalised, if satisfactory answers are given to the issues as detailed in section 3 below.
[When the PRAC adopts final recommendations to the CHMP, the following wording should be used instead:]
Based on the review of the available information on the status of the fulfilment of Specific Obligations and safety data submitted, the PRAC agreed by with the following advice to the CHMP:
[- Recommendations related to the assessment of safety data
- Recommendations on and changes to Specific Obligations within the remit of the PRAC
– Recommendations related to pharmacovigilance inspections]
[In case of safety-related requests by the PRAC (i.e. cumulative safety review to be submitted), please include the following sentence:]
As of Oct 17, 2014, the consensus forecast amongst 35 polled investment analysts covering Yamana Gold Inc. advises that the company will outperform the market.
Usually PRAC is technical body to CHMP ...adoption always results in approval otherwise they will say findings for review
06 October 2014
Pharmacovigilance Risk Assessment Committee (PRAC)
Pharmacovigilance Risk Assessment Committee (PRAC)
Draft agenda for the meeting on 6-9 October 2014
5.1.9. Naltrexone, bupropion
• Evaluation of an RMP in the context of an initial marketing authorisation application procedure
Status: for discussion and agreement of advice to CHMP
Product number(s): EMEA/H/C/003687
Intended indication(s): Management of obesity
For adoption: PRAC RMP AR, PRAC RMP Assessment overview and Advice
nce a bubble starts, a convincing narrative gains traction and the narrative becomes self-reinforcing. As George Soros observed, fundamental analysis seeks to establish how underlying values are reflected in stock prices, whereas the theory of reflexivity shows how stock prices can influence underlying values. For example, in the 1920s people believed that technology like refrigerators, cars, planes, and the radio would change the world (and they did!). In the 1990s, it was the Internet. One of the keys to any bubble is usually loose credit and lending. To finance all the new consumer goods, in the 1920s installment lending was widely adopted, allowing people to buy more than they would have previously. In the 1990s, Internet companies resorted to vendor financing with cheap money that financial markets were throwing at Internet companies. In the housing boom in the 2000s, rising house prices and looser credit allowed more and more people access to credit. And a new financial innovation called securitization developed in the 1990s as a good way to allocate risk and share good returns was perversely twisted into making subprime mortgages acceptable as safe AAA investments.
The successful completion of an efficacy study in an experimental Ebola virus disease model in non-human primates represents an important next step towards understanding the potential of BCX4430 as a treatment for Ebola disease in humans. NIAID, part of the National Institutes of Health, granted a contract to BioCryst in September 2013 valued up to $22.0 million over five years. With this additional award, the BCX4430 development contract has been increased in value to $24.4 million, if all options are exercised.
This project will be funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201300017C
NIAID is supporting the development of potential treatments is BCX4430, a drug that BioCryst Pharmaceuticals .
The lead BSAV compound is BCX4430, an RNA dependent-RNA polymerase inhibitor that has demonstrated broad-spectrum activity against more than 20 RNA viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses.
BCRX is developing BCX4430 in collaboration with U.S. Government Agencies following the Animal Rule regulatory pathway.
BCRX designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases.
NLNK fails and TKMR fails left with No choice but BCRX... atleast established a year ago that it works...
“because we’re going to need more than one drug to make sure, because the virus is adapting to us as we’re adapting to it. It mutates into different forms.”
Besides, we all have different DNA, and therefore different ways of reacting to certain drugs. Some drugs that work on one person may not work on another, and vice versa.
“…we’re going to need every single Ebola drug that we have to try to help these patients.”
“That means we’re going to need every single Ebola drug that we have to try to help these patients,” Paul goes on. “And then pray that they work.”
CEO is Garbage+Comedian = Every Lies he speaks he adds YOU KNOW !!!!!!!! Nobody knows only he knows and FDA knows he is bluffing....LOL