Monday, December 29, 2014 10:21:02 AM
1. Given the fact that nearly a year was lost with only one patient dosed during that time for Phase I, cohort 6, what steps are being taken to get the program back on the original scheduled timeline and to make sure that this problem does not re-occur on this and future planned clinical trials? I
2. Trial schedule estimates have been publically issued which have not even come close to being met. For example, a recent schedule estimate of starting phase II trials by the end of December 2014 was issued in a press release. No information has been released to state that this objective was achieved. Was this schedule improperly estimated by management or is there internal management problems that prevented the schedule from being achieved?
3. What steps are being taken for getting FDA "fast track" approval of reports, Clinical submissions and approvals for future clinical trials?
4. Is anyone is being held accountable for past program failures and schedule slippages? If so, who and how?
These questions are being submitted by individuals who, collectively have around 40 years experience in managing programs in the healthcare industry and in working with the FDA CDRH and CDER for medical devices and drugs.
What other questions do people have for BPTH managment?
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