How many cancer treatments used as current treatment are safe, effective and have minimal to no true adverse events associated with use? The answer is almost none. “The process” has made no provision for safe and effective treatments like L or Direct to be made available to patients with no other hope for long term benefit. “The process” could be changed by allowing temporary clinical trial methods for production immediately upon that safety and positive effect signal determination. To say otherwise is flat out wrong. “The process” assumes risk with use of a treatment and weeds out the most lethal and determines approval based on risk/benefit. Show me where there is serious risk to using L or Direct. If you can’t then tell me why patients have not been given at least limited access as of many years ago with set aside funds for something like L which has a Promising Innovative Medicines designation. “The process” stinks. Best wishes.
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