PharmaCyte Biotech Inc (PMCB)

[tulla236a]

from the fda on pre in meetings
http://www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf

The following situations are examples of when a meeting can be cancelled:
•
The sponsor or applicant determines that premeeting responses to its questions are sufficient for its needs and additional discussion is not necessary (see section VIII.). In this case, the sponsor or applicant should contact the CDER RPM or appropriate point of contact in CBER to request cancellation of the meeting. The division will consider whether it agrees that the meeting should be cancelled. Some meetings, particularly milestone meetings, can be valuable because of the broad discussion they generate and the opportunity for the division to ask about relevant matters (e.g., dose-finding, breadth of subject exposure, particular safety concerns), even if the premeeting communications seem sufficient to answer the sponsor’s or applicant’s questions. If the division agrees that the meeting can be cancelled, the division will document the reason for cancellation and the premeeting communication will represent the final responses and the official record.


VIII. PREMEETINGS AND COMMUNICATIONS WITH SPONSORS OR APPLICANTS
CBER and CDER hold internal meetings to discuss meeting packages and to gain internal agreement on the preliminary responses to a sponsor’s or applicant’s questions. We may communicate these preliminary responses to the sponsor or applicant. Communications before the meeting between sponsors or applicants and the FDA, including preliminary responses, can serve as a foundation for discussion or can be the final meeting responses. Nevertheless, premeeting communications should not be construed as final unless there is agreement between sponsor or applicant and the FDA that additional discussion is not necessary. Preliminary responses communicated by the FDA are not intended to generate the submission of a new meeting agenda and new questions. If, however, a sponsor or applicant provides new data or a revised or new proposal, the FDA may not be able to provide comments on the new data or it may generate the need for the submission of a new meeting request by the sponsor or applicant.