This can only be answered by the company however if you look at all of the trials that have been undertaken of IMM 124e as well as the trials that have been conducted by the US military as well as the fact that Travelan has been approved in Australia and over 200,000 boxes have been sold and consumed without any known adverse reactions I suspect that the cost of taking Travelan (IMM 124e) to approval by the FDA at this point will not in the scheme of things be significant given all of the information and trial results available.
I have copied the following from Passport Health's web site regarding Travelan under Q&A :Yes. Travelan contains bovine colostrum, a dairy product. The bovine colostrum in Travelan is harvested from Australian or New Zealand dairy cows, which are certified to be free from BSE. Each batch is pasteurised and tested to be free of antibiotics and microorganisms.
Over 200,000 packs have now been sold worldwide with no cases of drug related side effects reported either in the clinical trials or from consumers. Travelan is very safe to use.
The fact that this course of action is now being taken relatively quickly after the bringing on board of Berman and Jacobs and as part of an obvious drive by them since becoming involved to push the sales of Travelan it might be that it took Berman to recognise what was needed to propel Immuron to where it should be and Jacobs to carry out his vision. Total conjecture on my part but only the company can answer your question.
Remember Berman came to Immuron with a reputation for being able to drive value for shareholders.
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