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Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US, page-151

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10/06/21

15:41

Post #: 53772403
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Originally posted by Vinceanna: ↑

Alzheimer’s Decision Sends Positive Message to Aussie Biotechs

This is from Dr.G. Price Point of view:

A prominent US physician and consultant to Antisense Therapeutics (ASX:ANP), Dr Gil Price notes the FDA’s approval was based on complex data set. That being the case, Biogen will conduct a controlled trial for the verification of Aduhelm clinical benefit in patients with AD.

“But if Antisense Therapeutics produces similar data, we would expect a similar decision from FDA,” says Price, a former director of the Nasdaq-listed Duchenne muscular dystrophy (DMD) drug developer Sarepta Therapeutics.

Antisense is is planning to pursue FDA “fast track” designation for its DMD drug candidate ATL1102. DMD is an incurable muscle wasting disorder that affects one in every 3600 to 6000 male children.

The company is currently discussing the construct of a proposed phase 2b/3 trial with the FDA.

However Price says the FDA’s decision does not constitute a lowering of standards. “The FDA reviewed data in a very difficult therapeutic area, and made a reasonable decision that offers patients hope,” he says.

“Keep in mind that FDA has been working with Biogen over the past 10 years as a partner, more than an overseer.“

Antisense Therapeutics appreciates the culture at FDA for the development of drugs that treat rare diseases and hopes to build a similar relationship as we continue to move forward.”

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“But if Antisense Therapeutics produces similar data, we would expect a similar decision from FDA,” says Price

nice if he is speaking about Alzheimer’s, as one of our new indications, price will go gangbusters.

ANP Price at posting: 22.5¢ Sentiment: Buy Disclosure: Held
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Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US, page-151

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Ann: US FDA Feedback on Type C Meeting for ATL1102 in the US, page-151

Top Stories

Horizon firms up ore reserve for Boorara ahead of FY25 Q1 development decision

MinRes jumps 5% as the company meets production guidance – depressed iron ore prices be damned

ASX Market Open: ASX200 to rise for Friday session | July 26

Nine's staff strike as Paris Olympic coverage begins

Tissue Repairs soars nearly 32% on TGA approval for wound healing gel

Monadelphous inks $200M contract with Woodside to help build Pluto LNG – but will it make Scarborough cheaper?

Nova locks in NASDAQ US market listing at a value of only US$3.3M as ASX gets quieter and quieter

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