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210 days? Got us by the globes, page-7

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tewkleberry

1,858 Posts.

02/02/15

20:15

Post #: 14684872
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Originally posted by TomBombadil ↑

I have been poking around on the EMA CHMP website.

I am considering making some requests for information, about the delay and the process.
It seems like that is the end of the Chinese whispers I ought start at.

While I think it highly likely, there are explanations for most things, I find that as an investor I was totally ambushed by various possibilities during this process.

Thus any objective at disclosure and transparency by those involved failed utterly in my case. That is an indictment in and of itself.

#1
The original "claim" of a statutory limit on the time table of 210 days... While kind of accurate is a seemingly irrelevant number when it fails to mention

it is impossible to answer questions in less than 30 days due to set dates for replies...
Hence it can always easily and unavoidably be blown out to 270 days by two rounds of questions answered in minimum time. (and questions typically cant be...)

I thus find headline claims of 210 days(a non meaningful/partial number) misleading by omission.

#2
The regulations also indicate that companies and applicants cant be ambushed with new novel questions in the second round... However apparently its fine and kosha to say there are questions you don't need answers to ... until later, and then change your mind and say nope the second round of questions is the ones we said we did not need answered yet....

#3
The flat out delays in accepting answers, seems directly contrary to the spirit of the 210 day regulation.
I want to know by what procedure which applicant was >chosen< to be delayed.... basically WTactualF.

For me there seem to some serious questions of procedural fairness. That EMA and CHMP have as a stated policy to be even more transparent and above board than required by the EU law, I find this sequence of events to be highly conflicted with that.

If nothing else, to regain whatever confidence I can in the integrity of the EU system, I will need information that clarifies these issues. Fool me once shame on you, fool me twice....

So what am I doing here instead of asking there?

Two things.

#1 Don't see any point at all in asking for answers to questions now as the matter is under review. Noting that perhaps even responding here should wait until after the dust settles.

#2 Wondering what suggestions outside perspectives have for what questions the EMA and CHMP ought answer about its processes, and its apparent ability to act so surprisingly.

Not an invitation for whinge. On personal level I too am annoyed/frustrated/...
Its the intellectual level where I go nah.. that cant/should not have happened that I want resolved.

IMO. Somewhere between EMA/TIS/and the ASX announcement system, it is really quite likely something is materially broken.
I want to know what so I don't get burned again. I have no actual reasonable expectation of any of them being responsive and changing, I want to know what, they claim the rules that they actually play by are, so I don't get burned again.

Expand

The EU doesn't have an embassy in Aust as such, but it does have the Delegation of the European Union to Australia, who represent the EU here.
http://eeas.europa.eu/delegations/australia/index_en.htm

18 Arkana Street
Yarralumla ACT 2600
AUSTRALIA

General Tel: + 61 2 6271 2777
General Fax: + 61 2 6273 4445

Anyone feel like having the discussion with them about EMA shortcomings? May not serve any purpose at this (hopefully) late stage.

TIS Price at posting: 29.0¢ Sentiment: None Disclosure: Held
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