They say they will call for an FDA inspection first part of next year and expect to be selling alferon by mid year. It's a delicate balance - hempispherx wants to give a realistic time frame, but also allow time for any problems or adjustments.
I was there for the plant tour in August. the plant was down for cleaning and to prepare validations this fall for the FDA (they send data to the FDA on an ongoing basis). They are fully staffed. The past 18 months, they've run more than 10 batches through the bioreactor. If validations currently underway show same product as produced manually, they will call for FDA inspection beginning of next year and hopefully be selling by June. that's about all I know. They weren't really taking questions on the plant tour. It's complicated process - as Equells pointed out to me - "you understand we're making this up (manufacturing process) as we go along". hah... no kidding. The plant/manufacturing process is very impressive.
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