"During the CHMP meeting where the Oral Explanations (OE) takes place, there is no formal vote regarding the application. Instead, following the EMA voting procedures guidelines, the trend of the opinion of CHMP members is polled informally. If the trend is positive, the Rapporteurs and EMA Product Team Leader meet with the applicant to discuss key amendments to the drug label (SPC) and package leaflet and revisions of the draft proposal for SOs/FUMs. If the trend is negative, they meet to go over "possible options available from a procedural point of view." One important note regarding the informal trend vote: Where a trend vote has been recorded and notified to the applicant /MAH, it is not anticipated that the final formal vote will reflect a change in the opinion of the Committee, unless anything has changed substantially from the time of the trend vote to that of the final vote."
Here's hoping we get a positive trend vote. Or it's as good as finished.
TIS Price at posting:
18.5¢ Sentiment: Hold Disclosure: Held
