Just to let people know, though statins, h2 antagonists, PPI's and many other drugs are chronic drugs that patients could be on for decades, they are not safety tested in patients for decades prior to marketing. Drugs can only be safety monitored for limited periods of time and with limited numbers of batches and in limited numbers of patients prior to marketing. However safety testing is done as much as can be done considering the risk involved and risk is determined by several factors including MOA, known side effects, required dosage, length of time of drug therapy, potential drug interactions, scale of patient population,... Drugs are usually more dangerous the higher the dosage but not always. Drug interactions can be hard to find and dietary interactions can be harder to find and unique combination interactions with specific patients can be impossible to find. The more time a drug is in development the better the opportunity to safety monitor and the sequence is pre-determined with all the routine checks performed in preclinical and then comes what we all know in the clinical stage.
I say all this because safety monitoring with bryostatin has been comparatively extensive given where it is in development because of its prior oncology development efforts. Though it is a CNS drug it is apparent the safety risks have been determined to be defined and understood and normal continued clinical safety monitoring will be the protocol because there is no adverse event signals causing problems. It does not mean there could not be a future safety concern but that is a normal concern throughout drug development of every drug, nothing more and nothing less, and, the history here is comforting for safety.
The big question is does bryostatin reduce AD? Good luck to sincere investors.
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