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Message: Re: Zacks SCR Resverlogix Report 12/28/18

"we can all expect both adjudacation and completion by the end of June ‘19"

In slide 4 and slide 17 of the BIO CEO slides it refers to trial completion being estimated or expected in H1 2019. And in slide 20 it states "Maintain existing safety profile until trial completion, last dosing expected H1 2019." The only milestone that they currently define in the latest Corporate Update as happening in H1 2019 is last dosing. In various instances, Resverlogix uses the term "trial completion." How does Resverlogix define trial completion? End of dosing? Reaching the 250 MACE target? End of adjudication? End of safety follow up? Database lock? Top-line readout? 

I asked IR for clarification and received the following. Coincidentally, G1945V over on Stockhouse received almost identical responses.

Friday 2/22: "Thank you for following up. Please find below some points regarding BETonMACE:

   *   The trial will continue until 250+ narrow MACE events have occurred (estimated in H1/’19); narrow MACE events stand at over 220.

  *   We have not publicly disclosed the breakdown between adjudicated MACE events vs unadjudicated.

  *   adjudication of all 250+ MACE events is expected to take 2 to 3 months post trial completion.

  *   Top line data will be announced after adjudication completion, database lock and analysis.

  *   All material information / developments will continue to be publicly available in a timely manner once known.

  *   There is no hard stop at 3 years of dosing as the trial is events based. Patients remain enrolled until a MACE occurs. Adjudication and safety follow-up can occur simultaneously."

Tuesday 2/26: "In general clinical terms, completion of a study is typically defined as when the final report is issued from a clinical research perspective. As in BETonMACE, there are milestones within the study, which we have defined, and all material information / developments will be publicly announced in a timely manner once known."

I sent a follow up and am awaiting response. I asked:

"Is end of dosing in BETonMACE considered material information/material development requiring public disclosure?

Does the final 2-3 month adjudication and safety follow-up periods, which you stated can occur simultaneously, only start upon end of dosing?

Is last patient visit (end of safety follow up period) considered material information/material development requiring public disclosure? 

Is reaching 250 adjudicated MACE events the trigger for end of dosing in BETonMACE?

Is reaching 250 adjudicated MACE events in BETonMACE considered material information/material development requiring public disclosure?"

BearDownAZ

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Mar 01, 2019 05:12PM
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Mar 06, 2019 11:57AM
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