Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
Hi totti this is a beast up to 90000 bopd once fully operational! THIS is all or nothing however could be 50p / 1 pound one day many of us will do very well if that happens . rkh is a good punt as well i been buying small amounts with share deal earnings
I WAS IN IMM at 40 to 1.56 i sold and next day or so hit 1.90 i was annoyed for selling before results . Well imm failed it look where it is now lucky call that was .
ITS about 50 percent pass rate maybe im thick i thought it was a slam dunk . AS FDA ADVISE YOU THE ROUTE . Geni are smart cookies so i have my trust , Time line can go way over 90 days for approval but most of us know that .
De Novo-winning devices often lack effectiveness data, analysis shows
Published Oct. 13, 2020
By Nick Paul Taylor
Contributor
Jacob Bell
Dive Brief:
A significant minority of devices brought to market via the De Novo pathway lack positive primary endpoint data from a pivotal trial, according to a research letter published in JAMA Internal Medicine.
The paper, which went live Monday, describes an analysis of 63 FDA De Novo authorizations of moderate-risk therapeutic devices between 2011 and 2019. One-fifth of the devices were not evaluated in pivotal studies, and one-third failed to meet at least one primary effectiveness endpoint in those studies.
Only one device was found subject to an FDA-mandated postmarket study. The Yale and University of California, San Francisco researchers who wrote the paper discussed the value of requiring devices to meet pre-specified endpoints and undergo postmarket studies.
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Inside the EU medical device regulation
Dive Insight:
A low- to moderate-risk technology authorized via the De Novo pathway establishes a new classification category that can then open a floodgate for comparable devices to enter the market via 510(k) clearance.
The agency is working to finalize a rule on the De Novo process to “make it more transparent and predictable for manufacturers.” Even without it, use of the De Novo pathway has increased in recent years. FDA cleared 65 devices via the pathway from 1997, the year it was established, to 2012. From 2013 to 2019, FDA cleared 187 devices via the pathway. The authorization rate for 2020 is slightly outpacing last year.
It’s notable that De Novo-cleared devices can serve as predicates for products that come to market via the 510(k) route, which has been criticized by the Institute of Medicine and others as having a low bar for clinical evidence and oversight. As such, the regulatory standards for the De Novo pathway have implications for products beyond the 252 that came to market via the De Novo route between 1997 and 2019.
To assess the evidence needed to get De Novo medical devices to market, researchers scrutinized the moderate-risk therapeutic devices cleared via the pathway from 2011 to 2019. The search found 65 devices that met the criteria.
Twelve of the devices came to market without being evaluated in pivotal studies. Of the 60 studies run to assess premarket effectiveness, 17 missed at least one primary efficacy endpoint. The number of medical devices cleared without pivotal data, coupled to the prevalence of failed studies, shows many products came to market without positive results from a late-phase clinical trial.
Postmarket studies give regulators a way to confirm the safety and effectiveness of medical devices that have mixed or limited clinical data without delaying patient access by requiring more premarket work. FDA made limited use of postmarket studi
Lovely jubbley
GOOD LUCK WHO HOLD ..100000 order dont cut it with me . However will trade again if it drifts
IMO YES BUT MIGHT HAVE A SLIGHT PULL BACK AS TECHS VERY HIGH . if it keeps going like this 20p can be hit . its had a great run from 3.5p the other day however it was over 15p before ave ,GREAT TEAM HERE I TRUST THEM
IMO IS A FAIR TRADE FROM HERE NOT RAMPING ONE BIT OF GOOD NEWS AND IT WILL 2 BAG
GLAD I SEE THE LIGHT HERE OVERALL EVENS N MY TRADES
ON that spike and bank profits
Cpi is stuck in 12/13s im sure it will get over 15 by june ,
Sorry bad eyes yes you was not rude , Can we all get on on and have a nice board. PEACE IS GREATEST THING IN THE WORLD . HAVE A GREAT weekend all .I WAS WRONG HEID , soirry
HAVE A BIT of respect for older people ! Thats underhanded and you know that .DONT YOU HAVE OLDER FAMILY ETC FRIENDS . Im ALL FOR the banter but please be respectfull
AS i feel they are progresing and orders are getting better . Good luck all
Needs a breather then next leg
Catch the monkey
IN PROFIT now as had to average down
Good luck all soon see
HI PUB it is there choice no one forces people to buy shares . I THOUGHT you was leaveing shares ,
Imo 200000 a month yes orders might come in but from start to finish it be 4 months turaround , imo be carefull , yes great news but watch out for cash raise