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Sunday, May 31, 2020 8:31:54 AM
What they said at ASM:-
“We are excited by the progress that we’ve been making in finalizing the data and moving toward data lock, unblinding, and topline data. I will mention as a bit of context, when we set the date for this annual meeting back in mid-February---it seems like a lifetime ago---at the time we were in the late stages of the final data collection and confirmation. And as we all know all too well the world was very different. Hard to believe that was just two months ago. But the pandemic situation had not taken hold, even Italy only had a few cases, nobody was under any lockdowns and our contract research organization the CRO and our various service provider firms that we work with on this process of data collection and confirmation were working steadily with the hospitals that have been the clinical trial sites. Not long after setting the meeting date the whole world changed in a very big way as we all know. By early-March the hospitals had stopped by actually the beginning of March the hospitals stopped allowing the in-person monitoring visits that are necessary to check and confirm the data and they themselves became so overwhelmed that they really couldn’t help with the final data checking and confirmation, things like looking up pathology reports in the archives, when their emergency room and all of their wards at the hospital were flooded with patients.
“I’m happy to report that we have managed to continue moving the process forward, collecting the data. We developed some workarounds, like everybody. We’ve used Zoom, we’ve used email, we’ve used other information sources. We’ve gotten creative. And one of the reasons, we know that a lot of firms, companies who have scheduled their meetings for April have cancelled them and made plans to reschedule but we wanted to go ahead with our meeting because we’re proud of the progress and excited about the progress that we had already made and have managed to continue to make during what has pretty much been a shutdown for two months in March and April.
“And so, I wanted to just go through with you now where do we stand today and what do we believe will be the timelines to the remaining steps for announcing the data. Based on where we stand today, with the remaining queries, the remaining confirmations to be done with the hospitals, which we are assuming we will be able to do at least some work with during May, we anticipate that we will reach datalock by approximately the end of May.
My bolding.
So they were hampered by Covid restrictions from doing all the necessary data collection / query resolution.
Even though they got creative in finding alternative means.
Now we know that many Covid restrictions remain in place (not least in the UK), so it wouldn't surprise me if they are still stuck (through no fault of there own), with the last few bits of important data collection, however creative they might try to be.
And datalock was anticipated to be 'approximately' end of May.
It's unrealistic for shareholders to think that means it will be done by tomorrow.
My point is, they will be doing neither us or themselves any favours, by saying nothing in the next 2 weeks.
If they achieve datalock, then great. Just PR it.
If they are stuck due to a Covid delay beyond their control, then not so great. But same thing; just PR it.
If there is nothing communicated by PR in the next 2 weeks, it will just lead to speculation, probably mostly negative, and lots of 'have they / haven't they' type debate.
When they do achieve datalock, they may not have to PR it. But it would be daft not to.
So, bottom line, I'm advocating that they keep us informed, whatever the trial status is.
So if they're listening, that means I'd like a PR please, regarding current trial status in the next fortnight (next week preferably).
(It's what DI is suggesting they will do anyway. They just need to carry that through.)
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