Re: Next private placement/licensing agreement
in response to
by
posted on
Feb 07, 2019 11:24AM
"They don't need much to get BOM over the finish line"
Well, when the rules of the game and the goal posts keep moving, combined with not being told the score of the game (are reported events adjudicated?), it is really hard to know where/when the finish line is at.
In Sept 2018 and Nov 2018, Resverlogix communicated that they expected end of dosing by end of 2018, with top-line by Q1 2019. Then, guidance in December 2018 and January 2019 changed to indicate that end of dosing is not expected until H1 2019 and trial completion expected H1 2019. Notice that in the latest January 2019 Corporate update they do not say top-line data H1 2019. They don't even mention a top-line data timeline. This ambiguity could mean no top-line until H2 2019.
What is trial completion? End of dosing? End of safety follow up? End of adjudication? Database lock? Top-line data release? Are the events reported in the updates adjudicated or not? Why is there such a large range in the BETonMACE design slides for the safety follow up period (4-16 weeks)? Does safety follow up and adjudication happen at the same time such that once end of dosing occurs we would expect both adjudication and safety follow up to be completed in ~3 months? If patients are dosed until end of trial then why does the latest presentation indicate "treatment duration up to 3 yrs"? First patient dosing started November 2015, so if 3 years is now the limit have some patients started to come off of dosing? So many questions.
We really have no idea where and when the finish line is. Hopefully they take the opportunity at BIO CEO next Tuesday to address these uncertainties.
BearDownAZ