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Doc logic

10/14/22 1:17 PM

#521882 RE: exwannabe #521876

exwannabe,

The beauty of this treatment is that it is NOT a drug so labeling it as such is a mischaracterization common to many. As of now, it is a completely self derived biologic, activated and matured ex vivo very similarly to the way it would be in vivo if interfering signaling caused by the cancer was not involved. All that really needs to be compared between cancer types is the activation/maturation characteristics of the end product DCs which are known to produce treatment effect. The necessary activation/maturation characteristics of the DCs is the same for all solid tumor cancer types. When this becomes better known do you really think regulators and insurance coverage will be able to stand in the way? Safety is NOT an issue to prevent rapid extensions of labels which is unlike checkpoint inhibitors and CAR-T and evidence points to immediately available increased benefit for those being given Poly ICLC. Do you really think once that gets known by patients that demand won’t increase exponentially? I for one will be willing to put fuel on that fire if there is ANY push back from regulators or insurance once manufacturing is ready and L is approved.
Patients deserve better than they currently get from “the process” and the newer steps made to improve “the process” are expected to have a meaningful impact on access to these treatments. If not, patients will become united against any undue influence preventing their access to a treatment that comes from their own bodies. It comes back to the old adage “Physician, heal thyself” which Dr. Ralph Steinman worked on before his death and others found ways to make better to the point of breakthrough. Best wishes.
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biosectinvestor

10/14/22 1:25 PM

#521885 RE: exwannabe #521876

They already do this for compassionate use and have done so in the past.

This is not true. Once approved, any drug can be prescribed off label, and the primary issue will be insurance coverage. As previously explained, the 21st Century Cures Act addresses this and makes it much easier and faster to get off-label access. That's one of the primary purposes of the law, hence the title.