there appears to be a misunderstanding about the 800mg and 1200mg trial.The 1200mg trial was requested by FDA.The company naturally agreed. Why the 1200mg trial?
If the final dose is one of 600mg or 800mg the FDA needs to know what effect a double dose will have on the patient. Why? because people forget if they have taken drug etc and can do so again within the time period.
The optimal result for AVX is that their was little or no difference between 800 and 1200mg. If their was a marked difference in viral loads the recommendation would be to change all patients to the higher dose. This did not happen.
You also do not want 1200mg from a marketing point as it is a bigger pill.
On toxicity etc whilst this has not been disclosed as I understand the company , during the trial, is told of any problems in that area.There has been no ann on this so i am assuming that the 1200mg dose was not a big issue for toxicity etc.
800mg is want the company wanted.It was what big Pharm. was watching for.
One more hurdle jumped.
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