RE:RE:The longer big pharma waits the greater the chance they wiliCancerSlayer wrote:
Agree, but a BTD would help change that dynamic...there would be just too much to ignore (& too much to gain) with that degree of derisking, especially considering the oncology field generally has the highest BTD approval percentage. Per a report from Pink Sheet 16 April 2021, two-thirds of Breakthrough Therapy Deignations resulted in successful FDA approvals.
The BTD truly represents a significant turning point in a company's trajectory towards approval. Compared to Fast Track status, meeting the BTD criteria will more accurately tell Big Pharma that this is the real deal & warrants more serious consideration & timely access to patients. All JMO. Staying very optimistic...
Clarification:
Two-thirds of BTDs "in the oncology space" resulted in FDA approvals...when considering the other top fields combined, the percentage is around 40% (per Pink Sheet 16 April 2021).