Too right, Gassy. BD was a long-shot but well worth applying for. Failure here won't stop Tregus from applying for BD for Fragile X or TBI, and I'm sure that any deficiencies in this application will be addressed.
It is likely the FDA saw the Retts trial as being far too short for them to make a decision, and a tad too small. Evidence of efficacy was proven, and the scientists involved in the trial will attest to the amazing potential of Trof, but I think we all need to see how these patients go over 6 months before we can say for certain that Neuren have a drug that is truly effective. Four weeks just won't cut it.
I like the size and length of the trial for severe TBI being funded by the US army. Could have the best chance of BD if efficacy is shown in the P11 trial imo.
SP over-reaction, page-4
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