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Re: MI Dendream post# 373391

Thursday, 04/29/2021 2:15:35 PM

Thursday, April 29, 2021 2:15:35 PM

Post# of 705308
I can't recall any other data lock PRs other than NWBO and CVM. What I should have said is that TLD is usually released within 3 months of the public knowing about the end of a trial (in my anecdotal experience). This is just for clinical stage bios, where the results of all trial are material and are generally disclosed on a prompt basis. I know that NWBO's situation was very different since the end of the trial occurred in 2018 and they waited approximately 2 years to get the revised endpoints approved (at least by the UK and EU) prior to data base lock, so their data lock PR makes sense to me.

You are clearly the expert in this area and I defer to you on your experiences. My observations are very anecdotal, but I agree that a clear failure is usually PR'd right away.

I don't know anything about congresses or penalties associated with violating their rules. I just know that they company told investors they would release TLD in September, prior to even the database being locked. And I believe they had TLD at least by the middle of November. So this delay is surprising to me and I personally don't think it is because they are waiting on a journal article or ASCO. Plenty of other biotechs release TLD promptly, present the data later at an industry congress, and then publish the results later in a journal article. I'm not aware of a single clinical stage biotech waiting to release TLD for months and months while waiting on an industry congress abstract to be released or for results to be published in a journal. Do you know of any companies that have ever done it this way?




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