I'm curious why they are targetting the usa anyway at this stage. Another company I follow, Recce pharma are approaching phase 1 trials of their anti biotic. They already have FDA Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track. But the company has chosen to undertake phase 1 and possibly phase 2 or further in Australia. They then plan to present the results for FDA IND application I am led to believe. Apparently it is quite acceptable and not uncommon to do the trials here cheaper and under closer control.
As long as the data is formatted as per FDA requirements I am told it is perfectly acceptable for use towards an FDA IND application. Trials dont have to be approved by FDA or done in usa.
apparently Paradigm pharma is another example of a company applying for IND well into the trial process.
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