As 2018 begins, we now enter the end-game. The recent news release on January 11 entitled:

RESVERLOGIX RECEIVES FDA PROTOCOL ACCEPTANCE FOR THE ONGOING PHASE 3 BETONMACE TRIAL

Which stated the following: 

"BETonMACE top line data is still planned to be available around the end of 2018."

My question to the knowledgable members of this board is - What is the definition of top-line data?

My Google searches have yielded a whole new world of definitions and measurement that "narrowly defined three point mace" lives in:

          * the top line is the analysis of statistics that show whether the end points were met or not

          * The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use has established guidelines which have been adopted as law in several countries, but are only used as guideance for the FDA.  

          * top-line results usually refers to a raw calculation based on the kaplan-meir curves to calculate the p-values and the hazard ratios assuming that the data is representative of  the real world. 

          * A practical guide to understanding kaplan-meir curves defines the importance of selecting and defining trial criteria, patients, endpoints, time to event,  etc. 

          * The variables are many and they are complex, as is life. Predicting and projecting  mortality based on a small number of participants must be well defined so that data and interpetation of results is consistent across all trial sites.

          * The sample size must be statistically significant to predict safety and efficacy. 

This is really fascinating - Sometime around the end of 2018 there will be a top-line read-out of results on a percentage of the participants, say 50% whom have completed the 120week trial dosing of RVX-208 or placebo.  However, the analysis of sample size may require an increase in trial participants to provide  statistically reliable predictions of the results.

I take it that the main event of 2018 will be the top-line readout? Hopefully to be followed by an encore when the results are statistically proven. 

All the participants who have completed the trial in 2018 will be outside of the US. Presumably, the top-line readout, if successful,  will allow RVX to submit an NDA in Europe, which would enable sales and production in Israel, Europe, China, Taiwan, Australia, and all countries but those bound by FDA protocol. Am I correct on this?  

Chicagoest

https://en.wikipedia.org/wiki/Analysis_of_clinical_trials