Re: "Later this quarter we'll announce some orphan indications that we'll be going..
posted on
Jul 14, 2015 02:57PM
I agree with anyone's concern's as far as DM's, and thus RVX's, ability to give consistant, clear and accurate guidance. I have said before that their track record in providing good guidance has always and remains abysmal. Until they learn the basic rules of accuracy we will always suffer from a deep discount in the market. Even this business of receiving the "first confirmation for our ph3 clinical plan has been officially received" from "a European regulatory authority" is somewhat of an obfuscation. Some here I think are confusing this with the EMA (European Medicines Agency), it is not or if it is RVX is unwilling to confirm this at least at the date of the press release. When I asked why the authority was not named I was told it could not be released. So who have they got a confirmation from? Why say anything until you can say who it is? When I asked that question I was told that alot of people were asking questions about approval so they released what in my opinion is a piece of garbage. Again an example of extremely poor message control and poor leadership. If you want people to believe what you are saying make statements of fact that come to fruition and don't make statements that can't bear even the slightest of scrutiny. That way people will step up and invest.
On the topic of FDA approval, one thing that could be going on is that the FDA and RVX are discussing trial format. It is not just a question of approval to do a trial but what is included in the trial so that succesful completion results in drug approval. Most successful ph3's still don't result in immediate approval of the drug in question and I think the FDA is taking steps to improve the drug approval success rate.
Again wrt RVX, I think, great science and shoddy business practice