I have previously said that the requiment for more data to confirm the findings would not be a big deal, indeed being able to carry on with clinical development would be a very big win.
The FDA has asked for more data, they did not say that it must be in the form of a RCT.
The best way to confirm the results generated over the last 2 years is to replicate 001.
This can be done by compassionate use and given that we have every thing in place for launch we should be able to start now , we would however need to supply lots both passing current standards and some of lower standard. A registar would be in place. Protocol would be followed based on MAP score and the treating centre would be required to do all testing needed before any indiividual dose was released . MAP score would be used as a measure of responce. The registar would be live. Within in 1 or 2 weeks this could be given to the FDA as a ongoing responce to the CRL . Investors would no doubt just love been informed of results on a weekly update.
Why a trial?
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