The meeting today will allow the CHMP and the assigned reviewers to have their specific questions (based on ECYT's documentation thus far) to be addressed. At this stage the outcome could have been 1. rejection of application. no more data could have saved it. 2. No more clarifications necessary, can go to CHMP meeting for a vote. 3. Additional outstanding questions need to be addressed before a positive opinion can be rendered. It is understood that if ECYT can address the question satisfactorily, it has a good chance to be approved.
So this is good news, I think. Once the oral or written address to the questions has been pondered by teh CHMP members, they will vote on it. The earliest that will be is at the next month's meeting, though it could slip another month. At that point it is thumbs up or down. If up, it will be a few more months to get it officially approved.
Sentiment: Strong Buy
CHMP does not have approval authority so no approval or disapproval will come out of this meeting. They will issue an "opinion" and you won't hear about it until the minutes of the meeting are released. That is typically about two weeks after the meeting but they have been running behind. If they issue a positive opinion the final opinion can be out to day 277 or another several months. A positive opinion is what we are seeking here.
oral (or written )!!!!!!!!!!! explanation!!!!! that i think endocyte have do !!!!
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In cases where products are considered to be of major public health interest, a sponsor can apply for accelerated
assessment of their application. If granted, the 210-day review procedure is shortened to 150 days.
Committee request for additional information
Once the CHMP has the preliminary assessment reports or critique from the rapporteur and co-rapporteur, it
prepares a list of any outstanding issues the sponsor must address. A consolidated list of questions identifying
“other concerns” and/or “major objections” is prepared. These are sent to the sponsor with the CHMP
recommendation and scientific discussion. The clock will then be stopped (day 120).
The CHMP can make one of two recommendations:
1. The product could be approved provided that satisfactory answers are given to “other concerns,” and that the
indications, the elements of the summary of product characteristics, and other conditions for marketing are
amended as outlined in the list of questions.
2. The product is not approvable since there are “major objections.”
The sponsor has three months from the date of receiving the questions to respond to the CHMP. Sponsors are
permitted to request a three-month extension, if required.
Oral (or written) explanation
The CHMP will discuss the joint-assessment report and comments of other CHMP members. The CHMP may identify
additional issues which the sponsor must address in writing or during an oral explanation. If a sponsor wishes to
make an oral presentation, it usually has one month to prepare.
After the oral explanation and the subsequent CHMP discussion, the rapporteur will provide feedback to the
sponsor before a formal vote takes place. If the outcome appears it will be positive, a discussion may be held
regarding key amendments to the product characteristics summary and draft follow-up measures or conditions
Looking at5 the Dec agaenda and then the meeting hoghlights it looks like you need to get to the New Applications portion of the meeting before you get a decision. Since ECYT is on the Preautorizations Procedure Oral EWxplanations it looks to be another month at least before we see a decision. Of course that's just my opinion and I could be wrong.
I would also like to know if this means a push back to a future meeting.
Also, for the regulatory gurus out there, in the case of an oral presentation like this, is Endocyte allowed to bring advisors from Merck with them? If present, are these advisors allowed a speaking role? Or is Endocyte fending for themselves?