Re: Draft Checklist for Management
in response to
by
posted on
Jul 25, 2016 12:29PM
This Draft Checklist for management thread is a working draft of a shareholders checklist to mangagement. Please if you contribute to editing this above list, please just reply to the previous message, copy and paste the entire text of the previous version into your reply and also bold, underline or italicize your changes so that changes can be better tracked. Here is a link to my post from this morning with some additional resources to consider in edits and here is SanFran's original Checklist for Management post in its entirety. For starters, here is SanFran's 6 points that he started in his original Checklist for Management post.
1. Negotiate continuation terms on the Dart/City loan. This is "Job 1."
2. Give us an overview of the long range plan (for both companies). I think they have a very good plan (Star Factories...). Problem is, that I'm the only one communicating it. Isn't that their job???
3. Review IP coverage for us. New patents. Patent life. For both companies. We know that the term of the patents for 208 appears limited. Thus, we need to learn more about other patents. Don used to cover this topic in more detail... time for him to revisit that.
4. Update us in a detailed fashion about HepaLink and other licensing deal(s). What are their activities? When will the all-important revenue spigot be turned on? Do they have skin in the game? Are they paying for the Taiwan sites for BonM? What are the updates on the second licensing deal that we have been told at the Q1 and Q2 2016 updates that a second licensing deal was to be announced in 2016.
5. Give us more detail on the backup molecules for each company - and how and when they will be moved forward into the clinic. I say molecules, not molecule, as there is no need for any "Star Factory" to stop at only one backup molecule. Is Resverlogix pursuing the autoimmune molecule RVX-297, or another follow on molecule, or autoimmune indications? Is Resverlogix sitll on track to confirm an RVX-208 follow on candidate in 2016? Will this be for similar indications as for RVX-208 or for different indication(s). At the Q1 update, it was stated that several follow on molecules have gone through various animal studies for different indication. What other indications are being pursued? At the NYAS symposium, it was indicated that other applications of RVX-208 may include muscular dystrophy and liver fibrosis. What are the plans for these indications?
6. Orphan Indications: Which ones are going to be moved forward and when? What is the timeline and estimated launch date of the RVX-208 Phase 2 PNH trial? Is a H2 2016 trial start still a possibility? At the Q1 webcast, we were told that a PNH trial consisting of 30-40 patients as an estimated cost of 2-3 MM is still planned to launch in 2016. Is this still the case?
7. Make the AGM into a "shareholder summit", by webcasting the AGM, giving shareholders (both in Calgary and on the Webcast) ample time to ask questions and preparing more than a cursory presentation that mirrors everything we've seen before and repeatedly. Also, when is the anticipated date of the 2016 AGM?
8. Update on renal program. At the Q2 update we were told that by the end of 2016 that Resverlogix will have a Type B meeting with the FDA, pre IND for our new renal program, to review of top line PK data of the Phase 1 trial. Assuming that the Phase 1 New Zealand pharmacokinetic trial and FDA meeting go well, what is the plan and timeline for Phase 2/3 renal trial(s) going forward. BETonRENAL was mentioned at the Q2 update. Will this be a Phase 2 or Phase 3?
9. Update on BETonMACE enrollment and study sites. Are all of the planned BETonMACE study sites now active? If not, what is the timeline for their activation. At the Q2 update we were told that Taiwan BETonMACE involvement should be launcing by end of 2016. Will there be any other China study sites involved in BETonMACE? It was also mentioned in a past update that Austrailia was a possible BETonMACE site for more patients if needed. Is there any update on this, or is it still too early to know. Is the 125 MACE event futility analysis still on track for mid-2017?
10. Update on US sites in BETonMACE. At the Q2 update, we were told that by end of 2016 Resverlogix will have a Type C meeting with the FDA to discuss adding BETonMACE centers in US and review any outstanding requests from the FDA. We were told that "At the time of this meeting safety data from over 1,000 patients in the BETonMACE trial will be available, additional dose response work, MOA and liver biology work will be complete." Assuming that this meeting goes well, when is the earliest that US sites could be actively recruiting and how does this affect the original BETonMACE timeline? Resverlogix will also have a Type C meeting with the FDA by years end to discuss toxicology issues and go forward carcinogenicity program. Is there any update on the immuntoxicity rat study that was requested by the FDA. What concerns, if any, are there about the current BETonMACE protocol meeting FDA expectations?