But this is the reality !!! Even for personalized medicinal products, one makes the trial activities so regulated (for so called "safety") that nobody can pay it anymore and that it stops. Regulations and costs during R&D are a major and independent risk factor for patients.
My wife was diagnosed with GBM in November of 2016. She had surgery and the standard of care; concurrent chemo/radiation which had no positive effect. The tumor grew. She went through the screening process for ICT-107. Cells were harvested and the vaccine prepared for her. Even though the trial was suspended in June or July her oncologist petitioned the FDA to allow her to administer the vaccine to my wife and she got FDA approval. She started receiving the vaccine in November 2017 and will receive another vaccination 2/22/2018. Since the trial is suspended there is no placebo contraol. She is getting the vaccine.
Incredible
ReplyDeleteBut this is the reality !!! Even for personalized medicinal products, one makes the trial activities so regulated (for so called "safety") that nobody can pay it anymore and that it stops. Regulations and costs during R&D are a major and independent risk factor for patients.
ReplyDeleteThis comment has been removed by the author.
ReplyDeleteIn a similarly frustrating vein, it looks like Novartis is killing development work on IDH305 for financial reasons too.
ReplyDeleteHopefully the new FDA head, Gottlieb, will follow thru on some of the claims of streamlining approvals and lowering costs.
My wife was diagnosed with GBM in November of 2016. She had surgery and the standard of care; concurrent chemo/radiation which had no positive effect. The tumor grew. She went through the screening process for ICT-107. Cells were harvested and the vaccine prepared for her. Even though the trial was suspended in June or July her oncologist petitioned the FDA to allow her to administer the vaccine to my wife and she got FDA approval. She started receiving the vaccine in November 2017 and will receive another vaccination 2/22/2018. Since the trial is suspended there is no placebo contraol. She is getting the vaccine.
ReplyDelete