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RegisterApproved Pilot and Failed Pivotal Study [Study Assessment]
Dear Lucas,
Why cant the sponsor submit the pilot data for MAA and do the relevant invitro studies for MAA? I know Iam going off topic...that could be a solution.
Though regulators advise us for taking innovator from different batches, we know the pain of establishing BE if variability change for a different batch of the innovator. The regulators arent keen on suing the reference innovator until and unless it comes to light. May be you could share the entire data with the regulatory body and discuss on the BE and non-BE with different batch and have the regulators give a solution to it.
All the best.
Kind regards,
Tina
Why cant the sponsor submit the pilot data for MAA and do the relevant invitro studies for MAA? I know Iam going off topic...that could be a solution.
Though regulators advise us for taking innovator from different batches, we know the pain of establishing BE if variability change for a different batch of the innovator. The regulators arent keen on suing the reference innovator until and unless it comes to light. May be you could share the entire data with the regulatory body and discuss on the BE and non-BE with different batch and have the regulators give a solution to it.
All the best.
Kind regards,
Tina
Complete thread:
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 StudyTina 2014-03-18 10:28
- Approved Pilot and Failed Pivotal Study Ohlbe 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