It is not time to play aezs108 yet. We will get topline data at the end of 2015 or 2016. Three years is too long time to stay long with this high cash burning company. I see 3-5 rounds of dilution and maybe another reverse split before data. Right time to invest is apx. 6 months before expected data release, enjoy the run-up and sell just before data. It is highly unlikely that trial will be halted at interim because of efficacy. Interim analysis is quite early (after 128/384 events!) so the statistical boundary must be very high.
I also think that trial will fail. Dox, even at high doses is not effective enough. CLSN has a delivery method that has been shown to deliver 25 times more doxorubicin than IV doxorubicin into tumors and their 700 patient P3 trial still failed badly. Control arm was treated with sugar water.
Good luck to all and greetings from Finland
"I see 3-5 rounds of dilution and maybe another reverse split before data."
*Maybe* another reverse split after 3-5 rounds of dilution?
Hahaha! ONE more round of dilution will subsequently result in MASSIVE selling, followed by a slow trickle down to under a buck, followed by the inevitable reverse split.
I sure hope Roth Capital gets to handle to dilutive financing, though. They're really good!
Celsion's heat study did not work by binding dox to receptors like 108 does; it used a rise in temperature to release dox in the target area after it had been provided by IV... nothing in that strategy concentrates dox into the cells IMO and the thermal release mechanism sounds too sensitive to be that controlled in practice.
In the meantime I am looking for the NDA for 130 - very delayed of course. This will generate useful income if they can get it to market
I can't say. Depends on a number of things. First of all, where are we starting from? I would expect the price to hover around here ($1.75-$2.25 range) until we get results, although an NDA for 130 and subsequent approval will bump the price up nicely.
The two most important things are of course tied to the phase 3 for 108. If the DSMB peek mid trial shows good results, especially if they recommend early termination for effectiveness, the price will skyrocket, easily getting into the high teens or even mid twenties. Remember, there are 4 solid potential uses for 108, and signs of approval, especially with strong results, would lead people to see this as a potential billion dollar drug. Of course the amount of dilution will also play into this. Again, I expect a number around 35 million shares, but who knows?
The second important point is when and what kind of partnership agreement AEZS signs. This will obviously not happen until at least interim results are available, and again will depend on the effectiveness of 108 in the trial. The longer AEZS waits, and the more certainty we get towards approval before partnering, the better terms we will get.
Sorry I can't get more specific, but those are my thoughts right now.
Why should AEZS-108 prolong OS as compared to doxorubicin? AEZS-108 could be more specific by targeting only tumor cells and therefore having less side effects. But if you consider that the active part of AEZS-108 conjugate is same doxorubicin, why to expect OS benefit?
You should instead be asking what will the price of AEZS be when the company releases NEGATIVE results on AEZS-108.
This is the reality you will soon be facing, havenot.
And then all the apologists who have been pumping AEZS over the past year will be here complaining.
Well, AEZS victims, you'll only have yourselves to blame, as you WERE warned about this company.
Many, many, MANY times!