Ann: Immuron Aims to Secure FDA Approval for IMM-124E, page-10

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11/04/19

11:27

Post #: 38095102
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Originally posted by Fact Finder ↑

This is a very important question and I will not attempt to cover all of the advantages and you should do your own research but here goes:

1. In the US FDA approval will mean that every single medical practitioner will be advised of the approval of Travelan as a safe and effective treatment for TD and provided with details as to its use and prescription on a continuing and updated basis.

2. In the US many health insurers will only reimburse the cost of FDA approved prescription medications which should make purchasing Travelan more cost effective for many users.

3. In the US FDA approval for one purpose ie approval of Travelan (IMM 124e) for TD will allow medical practitioners to prescribe it for other purposes called 'Off label prescription' see https://www.fda.gov/forpatients/other/offlabel/default.htm Thus if FDA approval for Travelan (IMM 124e) can be accelerated due to all the matters raised in the companies announcement as well as the findings of the US Military then it will also be available for Off label prescription in respect of C. Diff and Nash in advance of final approval by the FDA.

4. In obtaining US FDA approval this will also accelerate the approval of Travelan in other countries for prescription as a treatment for TD where the countries have treaties in place for this purpose in this regard China comes to mind.

These are some of the advantages of FDA approval and as I said you should do your own research.

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Thanks for this response, Fact Finder. Also wondering why they didn't start the (costly?) process earlier then? Especially because Travelan has been on the market for quite a while and proved its effectiveness?

IMC Price at posting: 19.0¢ Sentiment: Hold Disclosure: Held
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