Re: Orphan Disease Program
posted on
Sep 25, 2015 02:09PM
I don't think the announcement of a Resverlogix orphan disease program has anything to do with the FDA. I think it is an excellent step but the "program" is within the company. When they announce the particulars of the first trial in the program, for PNH, then we will see if it is going through the FDA. I would imagine another ph 2 approval for RVX-208 would be relatively easy to get. Wrt to treating PNH I would doubt if RVX will be able to get an Orphan Drug Designation for RVX-208 as there is already a treatment in Soliris. Hopefully the childhood indication DM has spoken of is something else but then again it wouldn't be the first time he was wrong or misunderstood what he was speaking of.
As far as BETonMACE or a ph2 for PNH being baked into RVX's share price I am inclined to think not as with RVX's track record of missing deadlines and being generally unreliable as far as information flow goes I think many investors will wait until those events actually commence, if that is what their investment is based upon.
Regarding analysts, I hope I am wrong in my previously stated doubts that today will peak the interest of a credible analyst with a real following. I still don't see how RVX without a NASQDAQ listing will be of much interest, other than academic, to a top tier US analyst. Again, I hope I'm wrong. I still don't understand why RVX can't at least get coverage by a Citi biotech analyst, given the existing banking relationship.