Clinuvel

macgyver

Well-known member
@BIG BLUE NATION I'm not really sure its needed. The mechanism is there should PW decide to go to list on the NASDAQ, but since we have approval in nearly all the main markets (except Japan which I consider a valuable market because of the prevalence of XP there) I think PW is happy to continue without the NASDAQ. Perhaps when revenues are rock solid he will have the confidence to list there.
 

stmccallum

Active member
Hey all when is the Australian review scheduled to be completed? I have not heard anything lately.
Also what other countries beyond Canada will accept this review under the mutual recognition agreement?
 

mrdax

Moderator
What's the general opinion / perception on tga approval? Is it a slam dunk with FDA/ema in the bag, or can we assume they'll make a whole new assessment?

Anyone knows of a drug which is FDA approved (let's even ignore ema approval for sake of simplicity) and didn't get tga approval?
 

macgyver

Well-known member
@mrdax Slam dunk, perhaps because of FDA/EMA but certainly bolstered by safety data etc. It’s the PBS reimbursement I’m concerned about, though I think the small number of EPP patients in Australia should see it reimbursed but maybe not 100%. The fact Clinuvel has already been having discussions with the PBS/Medicare before TGA approval is even granted is encouraging, though I’m not sure if this is standard practise for Pharma companies when trying to enter the Australian market (pre approval reimbursement discussions that is).
 

stmccallum

Active member
@stmccallum wait, we get Canada ?
France,US, China, Oz and Canada?
Australia Canada Singapore Switzerland (ACSS) Consortium – Erleada approval
July 13, 2018
Our file number: 18-108470-709
On July 4, 2018 Health Canada approved the first drug to be evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s New Chemical Entities Work Sharing Trial. The Work Sharing Trial is an initiative under the “Regulatory Review of Drugs and Devices” and is aimed at strengthening our international partnerships in submission review and enabling a prompt authorization of the drug product to allow Canadians to have faster access to the medicines they need.

yes we get Canada too
 

Johnny H

Well-known member
Canada is a possibility.... if the application was synchronous and intended for simultaneous approval.

Clinuvel has not stated either way, which leads me to believe that they only applied to the TGA. I hope I'm wrong, because the normal approval pathway in Canada is at least 2 years, if not more.
 

Alexius

Member
Australia Canada Singapore Switzerland (ACSS) Consortium – Erleada approval
July 13, 2018
Our file number: 18-108470-709
On July 4, 2018 Health Canada approved the first drug to be evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s New Chemical Entities Work Sharing Trial. The Work Sharing Trial is an initiative under the “Regulatory Review of Drugs and Devices” and is aimed at strengthening our international partnerships in submission review and enabling a prompt authorization of the drug product to allow Canadians to have faster access to the medicines they need.

yes we get Canada too
I just saw that the 'Medicines and Healthcare products Regulatory Authority' (MHRA) of the UK joined this consortium on 14th of October 2020 as well. If I remember correctly, Scenesse is not available in the UK yet. May their affiliation in this consortium affect their decision of approving Scenesse?
 

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