They say "expect to reply in Q1", so I would take this to mean they will give their oral at the March meeting, so opinion from CHMP in April.
Question, they knew damn well in advance that there was to be no opinion from CHM at this meeting. Did they mislead investors or not?
My take on all of this. ECYT apparently has some significant questions from the regulators they have not yet addressed. ECYT is trying to pretend that this the expected course of action when it is not. It was quite clear in looking at the CHMP agenda that Vintafolate and the diagnostic were being discussed for a positive or negative opinion. You can also see via the archives the CHMP has where they have requested information from ECYT last year, I think in March and again in November. What is really bothersome in ECYT's press release is they give no indication what so ever on what the outstanding issue is, so I can only conclude from that deafening silence that it is pretty significant. This is enough of a big red flag for me to run far far away from ECYT until they sort this out, if they sort this out.
The EMA procedure spelled out at the end of the Agenda calls for 120 day and 180 day question periods, right in line with the April and November calls for info. During these periods the clock stops and starts again after the questions are answered. I'm going out on a limb here but I think this is part of the stop period after the 180 day questions and the call for oral presentation would be the end of the stop so whenever they present the clock will start again and the CHMP will have 30 days to issue an opinion. I don't read anything positive or negative into the asking for more info. It would be interesting to go back and research the drug that made the oral presention this week and see what their history is regarding timeframes.
Hey Fib, I see you and CH are both following ECYT. It's nice they know the questions that need to be addressed, I would like to see them disclose the questions. That would give shareholders a better understanding of the risks and probabilities. I have not invested in ECYT, still not sure/have not taken time to learn, how/how well/if the linkers work in a SMDC. Best wishes!
if I were a conspiracy theory nut job I'd say there's a concerted effort to get the SP down big before they finally say....well...ok....I guess so.
If in fact that happens watch the insiders.....especially Mr Low, down around where it tanked back in Oct.
When he says 1st Qtr, I take it to mean an oral presentation at maybe the Feb board and then a ruling in the March board. My question is, are these review boards the only time they have meetings or could there be a meeting prior to the Feb board where a recommendation is made?
Could be Feb, I just read the tone of the PR a little more negatively.
My understanding is that the EMA does everything locked to a 30 day cycle (which I think really means monthly). So when the clock is stopped, it starts up again at the monthly CHMP meeting. I do not think they can short cycle it in any way.