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pqr

04/29/21 2:59 PM

#373423 RE: Gus McCrae #373411

So GUS - if ur claimed knowledge is anecdotal based on 2 situations (likely entirely distinguishable), you don’t know about publication or ASCO procedures, you “don’t think [delay of TLD] is based on journal publication or ASCO” but you don’t say why you think or “don’t think” so and you don’t offer any other explanation for delay, why are you posting anything?! I’m pretty sure that the readers of this Board are aware that company management said TLD would be presented in September but thanks anyway for that nugget.
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foxhound02

04/29/21 4:22 PM

#373449 RE: Gus McCrae #373411

"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?"

The above is an outstanding post and in my opinion there will be no ASCO presentation. I suspect the unblinding revealed a problem that required revisiting the the original data.

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MI Dendream

04/29/21 5:20 PM

#373458 RE: Gus McCrae #373411

Well Gus, I only do research and post primary sources if I feel those who I care to speak to on this board will require proof to consider picking up what I am laying down. I don’t think that is the case here.

I will say two things... I have firsthand experience with a situation where I was in wave two of unblinding for a potentially game changing therapy. First, I was told, prepare for data in March, then no no May, and then it was actually July. Was data lock delayed 4 months? Hell no, what was happening was this...we presented at a conference in the fall (like 6 months post the likely lock), the conference was small and deadines were short, TLD was released in PR just prior to the conference and approval from FDA came before year end. Negotiations with FDA were happening that was the delay, but no one knew that was happening, and no one from the public knew that things were being pushed because milestones like data lock ARE NOT material information. The approval timing was a shock to everyone but the company. If one chooses to share, it is a choice.

Second, I frequently see clinical stage biotechs say...we expect results in the first half of the year, then we hear ... nope, it is coming towards the end of the year because enrollment was slower than expected. This is usually BS if you are paying attention because the timelines don’t match. The study duration doesn’t match what they are saying about enrollment. There is no way they could still be enrolling and make either time point for data release happen (there are exceptions to this re: study design like our original endpoint triggers here), they either knew they weren’t going to make the first projection when they gave it or the reason for delay has nothing to do with enrollment... aka data lock to release was longer than you think and you may never know the reason why.