I think everyone needs to realize that the side effects mentioned in a Keytruda commercial may be problems seen by a very small fraction of the people using the drug. In many cases side effects can be mitigated easily as long as they're anticipated.
In IMGN's recent approval of Elahere ocular problems were seen in many patients. For most patients the simple use of eye drops eliminated the problem. The point is, when you know something is likely to happen, you can be equipped to handle it and it becomes insignificant, especially when compared to lengthening your life and perhaps achieving a cure.
I believe that the FDA has made improvements over the years. Many years ago I know that one of IMGN's Phase 1 trials ended at low dosage levels because of severe headaches that the clinicians believed could have been mitigated by one of many headache remedies, Aspirin, Advil, Tylenol, etc. but the trial protocol didn't include it so it couldn't be done. No one will really ever know if the drug would have been effective if higher dosages were achieved as the company didn't choose to run an additional trial to find out, the drug was abandoned. Today I believe that clinicians are permitted to use readily available therapeutics, not included in the protocol, to treat problems which if left untreated could lead to calling DLT rather than achieving substantially higher dosage levels and perhaps curing the patient.
Trial protocols only lead to approvals, they do not represent how the product may be used most effectively. After approval we'll really learn how effective DCVax-L may be when Drs. experiment more with it. Schedule differences or other additional therapeutics could easily take 5 year survival well above the 50% range that UCLA is achieving, who knows if it couldn't lead to 75% or more as Drs. experiment and find better ways of using the vaccine and other available therapeutics.
Gary
Bullish
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