Re: Interesting Trades / Volume .....
in response to
by
posted on
Jan 26, 2019 10:53PM
C.D.,
I'm even more confused now than I was previously. Please clarify.
You first wrote "In many ways it would not be a prudent thing to announce when they hit the 250 mark or 270 or whatever. This might be key info and a timeline that an aquiring company would learn after it signs a N.D.A. and is let into the data room."
OK. Sounds like you're talking about BETonMACE initially reaching the "unofficial" 250-270 events, which then triggers the start of the trial wrap up (end of dosing, last patient visits, completion of adjudication, database lock, analyze data). Is this correct? Resverlogix will only have access to the unblinded data after the database lock, which would likely be at least 2 months after hitting 250 events and end of dosing. Completion of data analysis would be expected to take some time as well before being ready to issue top-line results. So are you suggesting that Resverlogix should stay silent and not give any public updates as to reaching 250-270 events, ending dosing, commencing last patient visits, completing last patient visits, locking the database and completing adjudication? This would be very unusual in comparison to the news releases that flowed out of Amarin's REDUCE-IT trial. Or potentially are you suggesting that Resverlogix withhold releasing top-line data to the public until it shows it to a company that has signed an N.D.A.? What are you suggesting would be covered under such N.D.A.?
Than you later wrote "If I may, let me clarifiy and expand my comment to my post as to why I feel it is not prudent for RVX to release the 250 / 270 etc. mace event numbers.....Large pharma will be doing it's D.D. from a data room that RVX sets up. Part of this process will be (let's hope we have three or four interested) large pharma recreating it's own models and predictor variable tests. They employ countless acctuaries, scientists that will be duplicating using the phase III data. The data that we have collected so far is a portion of our secret sauce. Timelines are very important when recreating models. So ante up big pharma, sign a NDA with a break away clause and see where our little gem would co mingle with your drugs which are coming off patents. I ask a simple question here, Why give away info for free?"
Same questions as above.
And then wrote "My scenarios all pertain to post FDA approval. I think it would be very foolish to do any deal this close to the finish line."
You made this statement in the context of the first two statements above. Post-FDA and/or EMA approval is way off. I would expect NDA/MMA applications to go out no earlier than Q4 2019 with potential approval not until 2020. So are you saying that you think Resverlogix will withhold announcements about trial milestones and data analysis until after FDA approval? I must be misunderstanding you.
And also wrote in reply to Cabel you wrote "i truly think that D.M. and co. would want a royalty deal after Betonmace is spun off ahead of an outright sale. I could be wrong and these are my thoughts. I think we are putting the cart ahead of the horse here. We need some truly great result and this all depends on numerous factors which are possibly a year or two away."
There already is a royalty deal in place with the Resverlogix Royalty Preferred Shares issued to Zenith Capital Corp shareholders. You talk about factors that are a year or two away? BETonMACE should be completed, analyzed, published and presented all in the next 6-12 months. Perhaps you are referring to the NDA/MMA applications and FDA/EMA approval? These will definitely take longer than 6-12 months. Or are you suggesting the BETonMACE will take MUCH longer to complete than current guidance?
BearDownAZ