Conference Call Minute 42: Christine: There is
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Quote:
Christine: There is a new initiative at the FDA accelerated cancer program. Are there plans to approach the FDA regarding this program?
Scott Kelly: I believe this question is centered around the concept of Project Front Runner which was initiated by the FDA oncology chief, Dr. Richard Pasteur. Normally accelerated approvals for oncology drugs are reserved for later stages of treatment and this initiative will push for accelerated approvals earlier and treatment and I truly applaud Dr. Pasteur for doing this, because the earlier you enter, begin in cancer, the less you might need the later line indications. So my understanding, it will be later this year before this goes into effect, but, Yes we will be pursuing this opportunity.