4 of 8 mice with panceatic cancer were cured and 5 of 8 mice with prostate cancer were cured with TH 302 added to exisitng treatment.- Is that correct?- That is pretty amazing. Not to mention THLD owns TH302- they invented it.
Ok, thanks, I'm satisfied. I suspected there might be a big labor cost, I just did not know there was that much left to be done after a couple of years of trials. I guess it was a shot in the dark, but in hindsight they probably should not have wasted their time. But, who knows? Perhaps after the G+G phase, Lily might make a bid.
TH302, G+G, 2DG: I am VERY encouraged. The fact that Selick himself would make what I thought to be an unscheduled presentation may mean the company thinks they've really got something here with TH302. Let's hope 2DG and Glufosfamide+Gemzar work in the third quarter.
'Twould be nice to get some positive surprises along the way, like this one (TH302).
Thanks, but I mean no offense: you are summarizing what is already known.
My point is: Why don't we know how much it cost???
But I suppose your other point is good, too, that perhaps it's not the cost in dollars but the company (i.e. labor) resources that it would have taken.
Still, I wish EVERYONE knew how much it would cost. This stock is depressed in part because it is not being run like a public, business company, just a research lab.
I have no idea how much it costs to submit a NDA to the FDA, but I think it would surely have been rejected - the study was so poorly powered that it didn't come close to generating statistically significant results, even though the survival impact was better than the already approved Tarceva (as a combination therapy, Tarceva increased median survival from 6.0 to 6.4 months, or less than 15 days versus Glufo's 21 day impact on end-stage patients). But in the end, the future of Glufo is its value as a first-line combination therapy, so management's time (and the company's money) is better spent focusing on those combination trials. Filing the NDA based on the P3 might have provided some short-term support for the stock, but I assume they will not be raising any money until after the third quarter, when the initial data from the combination study will be available. If you believe any of their compounds have value and they will generate enough news flow to get the stock price back to a reasonable range to raise some cash, then this is a huge buying opportunity?
You said it was a waste to begin with. I agree. They did not enroll enough people to bring down the p-value. However, people lived longer. But not long enough, etc.
My point is: since they already paid for the study, how much MORE would it cost to submit the data to the FDA? 1 dollar, 1 billion gazillion dollars? Or somewhere in between? If it is only say $500,000 (which I cannot believe it is that much), would YOU spend the money? I would. Or, at least, I would have SAID it was close enough to submit the data. That would have spiked the price for sure. Unethical? Probably not the worst thing they could have done. And, the worst thing they did was do a Phase that was DESTINED TO FAIL.
Again, how MUCH would it cost to submit the data?
Am I the only person who listened to the webcast? I would have expected the stock to go up at least SOME if only a few cents- I know THLD has lost alot of trust but I mean "cures cancer in mice"- come on- where are the buyers?
I listened to the presentation and believe there is alot of potential in their pipeline, but TH302 is a compound that is at least 5 years away from the market, and this data is not new, so don't expect some kind of pop from the presentation.
I think one of the reasons THLD's pipeline gets no respect is that their compounds are worthless as single-agent treatments - look at all the graphs that show the impact on progression is less than existing first line treatments (e.g. Gemzar) alone, but in combination show dramatic effects (i.e. 1+1=3). Given the mode of action, this makes complete sense, but this makes the clinical path for these compounds more complex and time-consuming - i.e. they have to do multiple phase-I and II trials in order to generate safety/dosing data first as a stand-alone and then in combination.
The other thing holding down this stock is that most investors will review their PR history and see that Glufo failed a Phase-3 trial and see that they are still pursuing Glufo in all these indications and not understand the distinction between the trials (i.e. the P3 being a stand-alone for end-stage patients vs. the current P2, which is testing Glufo in combo with Gemzar as a first-line treatment). The frustrating thing is to hear them talk about the failure of the P3 trial being a product of how sick the patients were (very few were even given more than one cycle of Glufo) and how hard it is to show efficacy in end-stage patients. So, if you know that your compound shows better promise as a combination therapy and that it is very difficult to show efficacy in end-stage patients that have failed first-line therapy, why go through the expense to run this trial - it was destined to fail and put your stock in the dumper for an extended period - it makes no sense!? Thankfully, they have enough cash to get through some of these other trials before they may have to raise money.