A Little More Research, page-5

First 5 Last

Share
Profile

Follow
thymus

1,993 Posts.

104

25/03/15

22:09

Post #: 14981278
Share

Originally posted by Revreboot ↑

Thanks Puzzled for the research. I started to do a little myself and then got bored. Before I gave it away I looked at 5 months of oral examinations at the start of last year - a sample size of 15 applications.

10 received a positive opinion at the following meeting or the one after that (66%)
All but 3 received a positive opinion eventually (within 6 months of the oral)
4 still had outstanding issues after the oral (all 4 received a positive opinion eventually)
4 received a negative opinion after the oral and all asked for a re-examination. They got it within 5 months but only one of these was ultimately successful
At least 1 application was found not to need an oral after all as they had addressed all the outstanding issues.

Hope all that helps in some way. I agree with Puzzled that we're comparing here against some pretty nasty drugs. As far as I can see CHMP has never required a "device" to go through this oral examination procedure.

Rev

Expand

Thanks Rev and Puzzled for the research.

I still think I think the crux of the matter is that the EMA has not previously dealt with a 'device' that also has pharmaceutical action.The fact that they have been forced by legal means to accept the device classification does not help either.

TIS Price at posting: 18.5¢ Sentiment: Hold Disclosure: Held
2 Upvote

0 Great analysis

Reply

Top Stories

SER

Strategic Energy extends its QLD copper-gold frontier with Diamantina acquisition

BDM

Burgundy plunges -20% after turning to layoffs to navigate record-low diamond prices

HotCopper Highlights: Trigg; Droneshield; Lumos & more

SYR

Syrah jumps +19% as graphite tariff threat spurs optimism down under

STN

Saturn brings up seventh straight Apollo Hill upgrade on 'impressive' 300-hole drill run

AII

A new NASDAQ listing for a key player in the global critical minerals space

DRO

History repeats for DroneShield investors but carnage so far subdued

ASX Market Open: Can we squeeze one more record reset into Week 29? | July 18

PSC

Prospect's Mumbezhi Project puts it at the middle of copper's megatrend. And FQM just bought in

Listen: HotCopper Wire Podcast 018 – Potatoes, TACOs, and the $120M helicopter heist

First 5 Last

Add to My Watchlist

What is My Watchlist?

A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.

A Little More Research, page-5

Top Stories

Strategic Energy extends its QLD copper-gold frontier with Diamantina acquisition

Burgundy plunges -20% after turning to layoffs to navigate record-low diamond prices

HotCopper Highlights: Trigg; Droneshield; Lumos & more

Syrah jumps +19% as graphite tariff threat spurs optimism down under

Saturn brings up seventh straight Apollo Hill upgrade on 'impressive' 300-hole drill run

A new NASDAQ listing for a key player in the global critical minerals space

History repeats for DroneShield investors but carnage so far subdued

ASX Market Open: Can we squeeze one more record reset into Week 29? | July 18

Prospect's Mumbezhi Project puts it at the middle of copper's megatrend. And FQM just bought in

Listen: HotCopper Wire Podcast 018 – Potatoes, TACOs, and the $120M helicopter heist

Featured News