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It hands the FDA guidance, not a rule

The compliance question is not the law, it is the source

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Considering the latter possibility, treatments that were considered failures in previous clinical trials could be reanalyzed for potential efficacy in ALS, taking into account the duration of the disease at the start of therapy. Therefore, using diagnostic criteria that enables earlier identification of the disease and a change in the physicians attitude towards offering an early diagnosis and treatment could result in better ALS patient outcomes.

BPC-157 250 mcg 2x/day SC + Ipamorelin 200-300 mcg SC 30-60 min pre-sleep