Why did NP say yesterday, that he couldnt provide

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Why did NP say yesterday, that he couldnt provide that data now, because the trial wasnt finished

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Here is what NP said (thanks trding) -

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what caused the additional delay so when we got the 50 patients that was going to be used for safety we wanted to make sure that we get that today immediately and we were able to do that however the FDA wants to see all the patients data from CD03 that that trial is not concluded yet it's not completed so when it's not completed now you have about 600 or 595 patients to be exact that you have to get quite a bit of information background you know
follow-up

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They've got raw data from those patients but it's not in any type of format for a BLA submission.

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Ohm, whats your opinion on Bored Lawyers argument?

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I'm guessing you're meaning this? -

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Is it simply an administrative issue where the FDA needs justification of efficacy at 700 in any HIV indication to allow CYDY to file the combo HIV BLA at 700 despite not running a trial at 700? - Bored Lawyer

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The safety data for 700mg should not differ between monotherapy and combo therapy so there would be grounds for using that. However data for efficacy between the two trials would have little comparison and shown by the two week virologic failure it does not.

One of the things the FDA wants in a BLA is clean data sets. Combining efficacy between two widely divergent trials would just muddy things.