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Ann: PARADIGM FILES FIRST IND WITH US FDA, page-4

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Troisi

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07/08/19

12:10

Post #: 39900238
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Originally posted by Gan_Gans: ↑

Congrats Paradigmers - Paradigm is in discussions and forming a relationship with the FDA. It seems I was correct about cGMP delaying the submissions.

People might think this isn't big news, as it only treats 10 people but I'd like to point out a few things about the "Early Access Program" in the United States.

The FDA will only grant an EAP to a drug if it ticks all these boxes:

* Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
* There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
* Patient enrollment in a clinical trial is not possible.
* Potential patient benefit justifies the potential risks of treatment.
* Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

It's actually a high hurdle to overcome, so if Zilusol is approved, you can bet the FDA is taking OA as a serious disease and that they are impressed by the data package PAR has submitted in their FDA.

I would love to be a fly on the wall when Paradigm casually drops to the FDA that they see a reduction in BMEL through objective MRI scans, and potentially Disease Modification.

Anyway, great news, FDA & PAR are talking. Big Pharma will see the IND being filed. Not too long now for the Australian TGA Provisional Approval submission that, (apart from a commercial deal) will be the near term catalyst for real fireworks in the share price.

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In the meantime at least the lab rats are on the improve!!

PAR Price at posting: $1.45 Sentiment: Hold Disclosure: Held
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Ann: PARADIGM FILES FIRST IND WITH US FDA, page-4

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