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So basically you (and ANP by their presentation) are saying that...

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BoomCrashOffera

720 Posts.

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29/08/23

07:01

Post #: 69601465
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Originally posted by dalts66: ↑

The accelerated approval pathway has been redesigned early 2023.

Basically they were sick and tired of companies being given an approval, reliant on an extension trial to provide extra data, not providing the extra data. The drug would go to market, the extension trial would not provide the required data, yet the company would not remove the drug from sale.

Now, an accelerated approval can be given from a Phase 2/2b trial (one carT received it from a phase 1b). An extension trial is required to provide data over a greater number of patients, which adds statistical significant data showing the drug works and is safe.

If this data is not provided, the FDA can remove the drug from sale.

Phase 3 trials are still required for indications where an accelerated pathway is not available, or for drugs which arent approved an accelerated pathway where one is available.

The whole reason for an accelerated approval is to get drugs to people with an unmet need as soon as possible.

There is a lot about this on the FDA website. As long as the drug is equal to or better than the SOC an accelerated approval should occur. Early CarT drug, for example, had a 75% adverse event rate, but had huge cure rates , for cancers that had no SOC. These drugs were approved, with a warning of the adverse events. As the FDA believes some chance is better than no chance.

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So basically you (and ANP by their presentation) are saying that the P2b trial is a pivotal trial as far as the FDA are concerned (assuming we pass the tox study).

I was always aware that accelerated approval was possible, but that the requirement for a P3 was also a possibility (unlike the EMA advice on the previous design).

Have they even begun discussions with the FDA?

No wonder they don’t even mention Europe.

Last edited by BoomCrashOffera: 29/08/23

ANP Price at posting: 5.2¢ Sentiment: Hold Disclosure: Held
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So basically you (and ANP by their presentation) are saying that...

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