Member Info for scoredagainsteps

Srange they lost nearly 300 the bid has just moved up

There getting more contracts now so very pleased at better profit .

I have a list OF DIRECTORS WHO HAVE RUINED COMPANIES and trust me over the years it has looked after me .As new companies they took over have gone down the pan .

What a great tie up with uni lever ..Stuff dreams are made of .I GOT PATIENCE and 1000 in 3 years here could be 20000

Nice start to the day I GOT TWO GOOD RNS TODAY ON MY SHARES

Regarding PATENT WITH UNILEVER nice that unilever commented on the patent exciting times coming here that's for sure

Just watch the sept 2023 half year report and there very honest . They dont fluff through questions like a lot of companies on the stock market , im holding to 2026/27 thats when the real gains are made . they admit this year heavy investment and cash burn of 750000 a month // correct me if im wrong . break even by mid 2025 and profits in 2026 . imo another cash raise will happen but when but this time better as geni should be over 15p so less dilution . I stand by my 50p a share in 2/3 years /PATIENCE REQUIRED . ALL THE best on this exciting journey

IT WAS GOOD LOTS TO come here as with all pharmas patience .Year of the pharmas THEY BEEN BEATEN DOWN NOW ITS THERE TURN

AS with pharma patience Imo under the radar however the 4 funds who invested dont think so . Show of confidence there .Might drop futher but slowly edge in with some nice buys .GLa

The new FDA goal is to review De Novo submissions within 150 calendar days for 70% of De Novo submissions, but how long does it take now?

If you would like more detailed information related to this video, please visit our blog posting discussing FDA timelines to review De Novo submissions:

➤ https://medicaldeviceacademy.com/revi...

Sparmanda agreed been saying this all week about cash .Once shell settled and cash raise and start date i will buy

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.

content imageAccess now➔

Image attribution tooltipImage attribution tooltipTRENDLINE

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