WRONG. Being granted orphan designation does NOT, in any way, increase chances of a product being approved or indicate a favorable view on a product by the FDA.
I've seen the statement "In the US and EU is is easier to gain marketing approval for an orphan drug" in a lot of places. However, I've never seen any actual evidence or statistics that support the claim...
Yeah it is great...if only Reolysin was an approved treatment. Marketing exclusivity means nothing until then. Maybe it makes the company more attractive to buyers? Need good trial results!
Isnt that exactly what I said about ODD, that it's meaningless unless FDA approval?
To your other comment, unless your assumption is that ONCY straight up lied in a news release, the statistics for patients with mutant KRAS speak for them self.
I think that's a fair enough point regarding the mutant KRAS subset. Though I don't think ODD correlates to a better chance of approval or illustrates the FDA's confidence in a product.
It's a gamble. The best trial results this far have resulted in "interesting" results. Other words, trials show perhaps a subset of the population respond to treatment....but really, this has been one disappointment event after another. To date, no phase 3 trials have met their primary objective. The pro ONcY posters on this message board have demonstrated a complete ignorance of facts. It's entertaining, but sad. That being said, im holdong out for a lucky buy out or a surprise news release with good clinical trial data.
Then why do so many patients have progressive disease after having been treated with reolysin? Also please note reovirus is NOT reolysin. Oncy only has ONE product and that is reolysin.
What exactly is misinformation in what he said? ODD is not going to be all that beneficial for ONcY unless REO is approved by the FDA. In other words, we still need to see good phase iii trial results and an application for FDA approval, and FDA approval for use before this means much.
So if it's denied ODD you think it will still go up or not get delisted?
Lol. In that time frame the stock will still be bust. You amd carri/others have been saying this stock will soar "in the next few months" for years now, but it's only gone down failed trial after failed trial. God willing no one seriously reads your BS and buys this coal.
Pretty sure he is because he got caught up in posting under the wrong one. I suppose I could be thinking of another nic, though.
Carriveccio/Bailey/Tall--you have been posting here for years under multiple nics. Don't be so modest! Congrats on being the biggest hypocrite on the message board!