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2 Aqueous Stability and Research Implications In lyophilized form, BPC-157 demonstrates stability at temperatures between -20C and -80C for extended periods

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FDA noted the refusals in the warning letter, reminding the firm that failure to respond to a 704(a)(4) request is a prohibited act under the FD&C Act, and then cited the company for several significant cMPG violations based on the on-site inspection