RE:“Designated news release””Good question. I assume the date, being one day after FY end was the first date they could talk about changing the trial parameters (maybe board needed to approve first?), so the date makes a bit of sense. As for that wording, I am also only guessing and think it is probably something in the ATM where there could be certain news releases that are more "material" and allows the broker to be brought "inside" and to decide if it changes their view on underwriting. But as we know, the prospectus for the ATM isn't underwritten, just placed on market by company, not Cantor. The other thing is it could just be some new way the SEC makes companies release news if it needs to be incorporated into the shelf prospectus sitting with them. Sort of like an identifier that it's material and it's not just a press release about an upcoming conference or something. Just a guess.
On the science side, remember I'm not the top medical guy here --others are but I learn from them and have tried to take on the data we've seen, the pre-clinical presentations and their own observations. One other thing we've learned from them is that there is also a plus and a minus with peptides -- On the plus side, the research shows the drug internalizes in 4 minutes on average (very, very quick which shoudl be good). It also clears out of the system fairly quickly too (good and bad --good for safety, but means 3 weeks is a long time to wait for another dose).
Purely speculating and they need to discuss this in general, but it could be you will never see much of an effect for some patients where they are very resistant to taxols regardless of how the PDC works differently. It just can't really get enough in there to do much and it's effect fades. How many of these hard-to-treat patients is that? Who knows. But for them you see no real effect, but all the safety issues, which is not a good trial patient. I think we have to know that part of this is, as they state, to try to "optimize" the rest of the trial --I take that to mean what we've been saying all along, given these 4+L "no option left" patients, it will likely only work in certain types of tumors and certain types of patients where taxols can still work. It won't be all, and as Qwerty has said, you only need 2 out of 10 and 4-5 out of 25 to be a huge success. This may increase the chances of seeing those 2 out of 10, but I don't know by how much it does that. I mean, you wouldn't change it around unless you thought there was science telling you it may just be better to drip in in weekly at lower levels so it's a more constant presence and doesn't just fade away into rapidly advancing tumor metastices and growth. Once in 3 weeks may work for some (like that prostate guy), but you'll see more if you lower it and do it weekly over a much longer period, and minimize safety issues.
It would behoove them to get all the data together and present the conclusions that led to this once they get it all and file it with the FDA --so maybe they can do that in 4-6 weeks and really bring a light and their logic around the dosing changes.
palinc2000 wrote: I dont have time to look for the definition in the Prospectus
Wino ? What are the consrquences ?