The way I see it., page-8

First 8 Last

Share
Profile

Follow
GiantLizard

63 Posts.

08/09/14

10:35

Post #: 13939046
Share

Originally posted by Revreboot ↑

This is my understanding:
IF the responses to the last list of questions was lodged on or before the 25th of July then Vitrogro will be discussed at the CHMP meeting in 2 weeks (the only reason I raise this as a potential issue is that the timing of the announcement of the lodgement gave little room for error about getting it in on time for the lodgement cut off date). At that meeting the CHMP will either adopt a list of outstanding issues which they will send to TIS/BSI to address OR they will give a positive opinion regarding Vitrogro. If they give a positive opinion they will convey that to the notified body (BSI) who then will issue a CE Mark. Given the workings of BSI in the past there is the potential for a delay before the issue of the CE Mark but hopefully no longer than a couple of weeks. If the CE Mark is issued then sales will start very soon afterwards, so potentially by the end of October.

IF a list of outstanding issues is adopted (rather than a positive opinion) then the clock will stop again and it could be months before TIS responds to that list of issues. Given past behaviour I would expect that to be about 6 months but it could be less or it could be more depending on the issues.

IF the responses to the last list of questions was lodged after the 25th of July then the above procedure will take place at the October CHMP meeting.

This is my understanding only. Please DYOR.

Rev

Expand

Thanks Rev

im sorry to be a pain by asking a follow up question....but I will!

can there be a list of outstanding issues where there have been no further questions since our last reply? To some degree (barring completely rejecting our answers) the lack of questions and the Committee having outstanding issues would seem to be mutually exclusive

thanks

GL

TIS Price at posting: 42.0¢ Sentiment: Buy Disclosure: Held
Upvote

0 Great analysis

Reply

Top Stories

ILU

Rare earths stocks surge as Pentagon buys big stake in US REE miner

CWX

Carawine faces Fraser Range JV collapse as IGO moves to scrap partnership

VMM

'Big tick': Viridis positions for global leadership with Colossus pre-feasibility study

Listen: HotCopper Wire Podcast 017 – RBA holds the toppings

Trump just dropped a 200% tariff bomb. Here's how to cash in

HotCopper Highlights: RIP to Botanix (for now); Droneshield new ATH; Trigg mystery halt

AAU

Antilles brings Chinese ally on board to keep Neuva Sabana work chugging on

Week 28 Wrap: Tariff chaos back for some reason; CBA holds strong

LIS

'Opens doors': Li-S Energy the first Oz company to produce lithium metal foils

AII

Inside the depths of Panasqueira: A legacy carved in rock

First 8 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.

The way I see it., page-8

Top Stories

Rare earths stocks surge as Pentagon buys big stake in US REE miner

Carawine faces Fraser Range JV collapse as IGO moves to scrap partnership

'Big tick': Viridis positions for global leadership with Colossus pre-feasibility study

Listen: HotCopper Wire Podcast 017 – RBA holds the toppings

Trump just dropped a 200% tariff bomb. Here's how to cash in

HotCopper Highlights: RIP to Botanix (for now); Droneshield new ATH; Trigg mystery halt

Antilles brings Chinese ally on board to keep Neuva Sabana work chugging on

Week 28 Wrap: Tariff chaos back for some reason; CBA holds strong

'Opens doors': Li-S Energy the first Oz company to produce lithium metal foils

Inside the depths of Panasqueira: A legacy carved in rock

Featured News