No such message found

...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Re: I'm not ready to throw DM and other management under the bus...

Koo wrote: "(IMO) I honestly believe that nothing will drive the share price up but the successful results from the Phase III trial. Had Resvelogix succeeded with ASSURE it would be a different story. We simply got to wait it out. I can't see what management can do at this stage of the game to lift the SP."

Well, 2018 is a long ways away and a lot can change. You could be right and a successful Phase 3 could be the driver. But expanding the RVX-208 market with renal trials (below) and PNH trial (we're still hearing that this is likely a go for 2016 or 2017), as well as potentially getting one or more new follow-on molecules into trials for other indications could be catalysts as well. Yes, it sucks that ASSURE missed its primary endpoint. But w/o SUSTAIN/ASSURE we would not have our impressive post-hoc analyses showing the optimal patient populations. Now with a better understanding of RVX-208, better patient selection criteria and more refined endpoints, successful Phase 1/2 trials for renal and PNH could help here to improve the confidence in RVX.

I'm also curious to see how, if at all, the scientific community, analysts, and investors respond when the NYAS Epigenetics: Cancer and Beyond webcast from April 28th is available (should be sometime in the next 3 weeks) and perhaps more importantly when the ESC 2016 Epigenetics/BET inhibitor symposium happens in late August. I saw the live NYAS webcast and thought that Ewelina Kulikowski for RVX and Eric Campeau for Zenith gave great presentations. It's NYAS standard practice to have ~8-10 week delay from live event to webcast availability, so we'll all be able to enjoy these soon enough.

Lastly, the Zenith butterfly effect is something to keep in mind. If they can show for ZEN003694 safety, efficacy and ability to perform daily dosing (something no completed or published pan BET inhibitor has been able to do), then they may have in hand the best pan BET inhibitor in trials. Think of all the potential Zenith trials that could be completed prior to the end of BETonMACE in 2018. Cancer trials move much faster that cardio trials. A Zenith success would have a ripple effect on RVX, IMO. If they can show safety and efficacy with a pan inhibitor of both bromodomains, then this increases the confidence in our BD2-selective RVX-208. Validating the platform and the company(ies) and perhaps cementing these two companies as the world-wide leader in BET inhibitors.

Again, I could be completely wrong. But these are just a few examples of what could happen before BETonMACE concludes in 2018.

Renal Trial: According to DM, by Q4 they'll have finished the Renal Phase I and launching the full blown dialysis BETonRENAL trial by early 2017. Since this is with RVX-208 and other ~6 month long Phase 2 Trials (SUSTAIN, ASSURE) have been completed, I'm wondering if they can go straight to Phase 3 for BETonRENAL. It is my understanding that the purpose of the New Zealand Phase 1 is to ensure that the drug is metabolized similarly in patients with severely impaired renal function. Best case: straight to another Phase 3. Worst case: Another Phase 2. Implication: Instead of being limited to ACS Patients with Diabetes, RVX-208 market now expands to: 1) Dialysis Patients; 2) ACS Patients with CKD; ACS Patients on Dialysis (see slide 24 of the Corporate Update). According to that slide the renal population comprises over 75% of the Annual MACE event rate, whereas the ACS patients with Diabetes comprise only 9.5%. So huge opportunity for expanded market with these renal trials.

BearDownAZ

Share
New Message
Please login to post a reply