What you say could be correct, it's possible, but it could be other factors also.
It is also possible the 6-month tox monkey study and the recent trial are just evidence put forward to validate an increased dosage or increased treatment timeframe.
The FDA has to re-address any prior adverse effects, whether they were an error at the time or the dose was 1000ml or whatever, we don't know what dosage Teva used, but at a guess, I would think it was more than 200ml or and higher than 1000ml per week, and then bodyweight is also relevant.
So many variables, so much speculation, and potentially there may be no real hurdles that are difficult to get past, we just don't know.
The announcement suggested to me the path forward would be attended to with positivity expected.
There's a fair bit of speculation at the moment and only time will tell.
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