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Re: None

Friday, 05/10/2019 12:33:19 PM

Friday, May 10, 2019 12:33:19 PM

Post# of 459742
Compiled: AUSTRALIA'S TGA: 05/10/19
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Australia may get us Canada:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148710704&txt2find=tga

Aussie P2/3 - link to study:
https://www.australianclinicaltrials.gov.au/anzctr/trial/NCT03790709

AIBL study (Australian Imaging Biomarker Lifestyle Study)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148157259&txt2find=AIBL
Study was cited by Missling:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148154210

April 5 2019 presentation to Australian healthcare workers concerning new trial approval protocol:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148220574

The timeline and requirements for provisional approval in Australia:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148221459

AUSTRAILIA TGA is different from the U.S. FDA

https://www.slideshare.net/TherapeuticGoodsAdministration/clinical-trials-tga-role

Arguments for accelerated approval for 2-73.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143620275
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143624077
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144651100
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144731123
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144982778

On the possibility of miss diagnosis in Australia.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148065519

2014 paper on diagnostic accuracy in Alzheimer's in Australia:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148065519

The facts about clinical trials performed in Australia:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148074963

Provisional approval in Australia may not require completion of the P3.. (links thanks to JonJones325)
https://www.tga.gov.au/publication/provisional-determination-eligibility-criteria
https://www.tga.gov.au/publication/provisional-determination
https://www.tga.gov.au/presentation-provisional-approval-pathway-prescription-medicines

December 2018 discussion of Possible Provisional approval in Australia:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145445997

Definition of Major Therapeutic Advance in Australia:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144734105

Feedback from Down Under - KaRa MINDS Institute participating as of 10/19/18
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146469112

Speeding up trials in Australia:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144956115



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