Re: Rodman and Renshaw Conf
in response to
by
posted on
Sep 13, 2016 04:27PM
Masila,
I will just add a few more tidbits. If it's in quotes, I tried to quote DM word for word. No mention of AGM.
Licensing/parterning deals: “We will announce a second licensing deal shortly.”
Analysts: “An additional analyst has come on already. We expect two more.”
New molecules and new indications: Seven new follow on molecules. They will be working with various indications in parallel. “We have already confirmed a 2nd compound, but we have not put it in an IND yet so I didn’t give it a thumbs up”.
BETonMACE enrollment: They are about a quarter enrolled (we heard this last month with the DSMB news release). They should have over 1000 patients by end of year. They are still planning for 2400 patients and are considering adding 2 more countries, though he didn't say which ones. USA (if FDA approved?); Taiwan (not sure if launched yet); Austrailia (previously referred to as back up if needed).
Update on FDA/US BETonMACE sites: Rodent/animal immunotoxicity experiments are complete and data has been compiled/analyzed. DM has seen the report and it came in exactly as predicted and there were no concerns. “FDA required work has been completed.” They are still planning to have their FDA meetings by end of year to discuss addition of US sites.
Orphan/Renal Trials: “Orphan indications are being launched” was the statement made on the final side in regards to the anticipated milestone of Phase 2/3 trials with RVX-208 in PNH and/or dialysis. Earlier DM mentioned that the renal team is finalizing study design at meeting in November and roll out programs on this early next year. One of the year end FDA meetings is to review the New Zealand Phase 1 Renal trial.
Manuscripts: “3 of 4 manuscripts are now complete”