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BonelessCat

06/18/12 6:21 PM

#60514 RE: maxxam #60513

cGMP manufacturing facility requires a specialized clean room with closed filtered air system. 12,000 sq ft is hardly a football stadium that can accommodate large scale, specialized production equipment in an efficient assembly line.

Also, to answer your question on a previous post, current facilities are sufficient for one tox profile of one drug, and possibly one small human Phase 1 trial. It won't be sufficient for each of 3 or 4 drugs as they enter various stages of pre-IND and IND enabling testing and trials.

One last thing, cGMP will open the door to IND enabling, but there also must be formulation testing (either 3 or 5 batches, not sure which) and some of the stabilization testing cannot be used in trials. All totaled, that's a lot of material for FDA testing, even if some of the FDA trials take place out of country.