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Re: exwannabe post# 100970

Tuesday, 02/07/2017 6:11:27 PM

Tuesday, February 07, 2017 6:11:27 PM

Post# of 696722
Nope. that was separate and apart.

On February 3, the FDA lifted the partial clinical hold which had been in place on the Trial.

As previously reported, the Company has been in an ongoing dialog with regulators.

The dialog culminated in the FDA lifting the partial hold.

As previously announced by the Company, and as the Company also informed the FDA, the Company has closed enrollment and is not going to enroll the last 17 of the planned 348 patients. NWBIO, February 6, 2017



That was originally done 60 days before. Your theory neither holds contextual nor procedural water.

Exwannabe said:

That the FDA viewed NWBO's complete response sufficient to prevent further patients from enrolling in a futile trial.

How could the FDA not consider this response adequate? NWBO did exactly what the FDA was forcing.

Once NWBO submitted the latest response, the FDA had 30 days to act. And they did so in the only rational manor. -- Exwannabe



By the way, I did not know they worked in a manor.

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