My guess is that we might hear of acceptance or ap
Post# of 72446
Posted On: 11/05/2015 9:43:08 AM
My guess is that we might hear of acceptance or approval for Orphan Drug status for K in pancreatic cancer fairly soon. That itself may not be a SP mover (or not move it a lot) but it will be further validation that there's some good data.I need to read up on what that status will give ctix exactly. I'm guessing it may expedite the pathway somewhat?
Slcimmuno posted the following interviews on the other board quite a while ago but I thought it might be relevant to repost them here as an example of how the trials for K could potentially be sped up significantly in the near future.
4 Part Vid Intvw w FDAs Richard Pazdur (Head Onc guy)
bodes well for Kevetrin if results are as good as we think they might be. the interview covers a lot of ground. he mentions "there's not going to be one drug that cures 8 cancers." maybe. maybe not. but that's the p53 dream. well worth a listen -- hearing the scoop straight from the FDA's regulatory top dog.
Cancer "Rocket Docket"
http://bcove.me/ndarcfh0
Patient Power
http://bcove.me/uawobpqd
Precision Medicine
http://bcove.me/xamojt6a
Compelling Case (pediatrics)
http://bcove.me/rtyf8t0p
The Gatekeeper to New Cancer Drugs
Dr. Richard Pazdur is the world's most important cancer drug regulator
Dr. Richard Pazdur, director of FDA's Office of Hematology and Oncology Products, tells BioCentury why FDA is racing to approve new cancer drugs. Dr. Pazdur says new targeted drugs and immunotherapies with unprecedented efficacy are the payoff from 20 years of basic science. He calls for greater patient engagement in drug development, says compassionate access should be improved, and predicts rapid uptake of biosimilars.
Slcimmuno posted the following interviews on the other board quite a while ago but I thought it might be relevant to repost them here as an example of how the trials for K could potentially be sped up significantly in the near future.
4 Part Vid Intvw w FDAs Richard Pazdur (Head Onc guy)
bodes well for Kevetrin if results are as good as we think they might be. the interview covers a lot of ground. he mentions "there's not going to be one drug that cures 8 cancers." maybe. maybe not. but that's the p53 dream. well worth a listen -- hearing the scoop straight from the FDA's regulatory top dog.
Cancer "Rocket Docket"
http://bcove.me/ndarcfh0
Patient Power
http://bcove.me/uawobpqd
Precision Medicine
http://bcove.me/xamojt6a
Compelling Case (pediatrics)
http://bcove.me/rtyf8t0p
The Gatekeeper to New Cancer Drugs
Dr. Richard Pazdur is the world's most important cancer drug regulator
Dr. Richard Pazdur, director of FDA's Office of Hematology and Oncology Products, tells BioCentury why FDA is racing to approve new cancer drugs. Dr. Pazdur says new targeted drugs and immunotherapies with unprecedented efficacy are the payoff from 20 years of basic science. He calls for greater patient engagement in drug development, says compassionate access should be improved, and predicts rapid uptake of biosimilars.
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