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RegisterApproved Pilot and Failed Pivotal Study [Study Assessment]
Dear Tina,
They could have done that before, rather than running new studies. Now it's too late: the new studies are there, and they fail, whatever the reason. Applicants have to submit all data available, whether passing or failing, and I don't see how they could defend submitting with a passing pilot but a failing pivotal, unless they find a very, very good explanation. Hiding the failing studies is no option.
❝ Why cant the sponsor submit the pilot data for MAA and do the relevant invitro studies for MAA? I know I am going off topic... that could be a solution.
They could have done that before, rather than running new studies. Now it's too late: the new studies are there, and they fail, whatever the reason. Applicants have to submit all data available, whether passing or failing, and I don't see how they could defend submitting with a passing pilot but a failing pivotal, unless they find a very, very good explanation. Hiding the failing studies is no option.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27
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- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study kumarnaidu 2014-03-18 05:03
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study - same test? Dr_Dan 2014-03-18 11:30
- Approved Pilot and Failed Pivotal Study - same test? Lucas 2014-03-18 13:38
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 10:28
- Approved Pilot and Failed Pivotal StudyOhlbe 2014-03-18 11:15
- Approved Pilot and Failed Pivotal Study Helmut 2014-03-18 13:06
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 15:55
- Approved Pilot and Failed Pivotal Study luvblooms 2014-03-19 05:16
- Approved Pilot and Failed Pivotal Study kumarnaidu 2015-12-08 07:02
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
Ing. Helmut Schütz