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Compiled: AUSTRALIA'S TGA: 09/29/19

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XenaLives Member Level  Sunday, 09/29/19 11:40:27 AM
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Compiled: AUSTRALIA'S TGA: 09/29/19
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Ern Haven Youtube


Valarie Lynch



The Case for Provisional Approval

AUSTRALIAN DEMENTIA FORUM
Accelerating research. Enhancing collaboration. Creating change.
Hotel Grand Chancellor Hobart, 13-14 June 2019
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151146610

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


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


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



“These findings show Australians want future access to breakthrough medicines. What is critical is to balance this innovation and affordability with the expectations of Australians. This will challenge some of our long-standing healthcare policies. We only have to look at the evolution in precision medicine and the impact targeted therapies can have on health outcomes and costs.” (from kevli33)
https://medicinesaustralia.com.au/from-the-chief-executive/new-findings-confirm-australians-place-high-value-on-the-pbs-but-acknowledge-its-shortfalls/

Discussion of possible commercial sales under Aussie SAS program:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149077207
More info on SAS:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=1471727

Australia sees the need for population based screening for dementia:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148875697

Australia - possible preparations down under
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151146610
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150922608
The Australian attitude toward healthcare is 180 degrees away from the U.S. for profit system.

AUSTRAILIA TGA is different from the U.S. FDA

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

Top 20 pharmas with an Australian company that would make a good Anavex partner:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148731195I
See note on the above:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148733750

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


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


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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