RE:RE:RE:RE:RE:RE:RE:Not surprisingAgain, communications with shareholders, all shareholders is awful. If they have data proving that the concept is working, and that's it's only a matter of wrong patient selection, too ill, not overexpressing sortilin, resistant to docetaxel, then we should know it. It would change my view on this whole thing completely, but they are hiding information and I don't know why.
At the very beginning of the phase Ia, they held an oncology webcast with Beliveau and all that. When they had no data on humans they were very willing to talk, now that they have a lot of data they are hiding it as some sort of big secret. The reaction of the market today shows how their press release was percieved.
Wino115 wrote: Some of that was "distributed" to the market via analyst reports. Some may be online by now and probably IR would send you a few to help understand it.
A few of the analyst reports mention it and say things like:
"...the company continues to explore patient enrichment opportunities;" so they discussed at least the general idea about patterns to help them optimize enrollment and efficacy.
One analyst states "Ultimately, a Phase I trial is intended for signal finding, dosage optimization, and risk analysis" and that dosing regimes start as educated guesses based on the lab data and usually get changed over time as they learn more.
One guy talks about how it's all about how to get your best "potency", which I think is what they're after. If PDCs lend themselves to frequent lower doses, maybe you can impact potency enough to get over the hurdle.
On Qwerty's question, while my efficacy definition is like yours --just find me 2 out of 10. It sounds like THTX must have seen the smallish sample was leaning the wrong way, so let's get on that now because if you believe the academics and our lab, we "should" be seeing that constant improving trend and not a jump and stop or up and down trend.
I sort of wonder if by looking to optimize "potency" you aren't taking away what may have been seen with the suboptimal one and done for 3 weeks results. But by changing the dymanics of both size, frequency and total dose over cycles, you might only get to see if it's more positive, and not more negative. In otherwords, if it just doesn't work (which we hope is not the case), then it may not matter and you still get the one and done 3 week result. But the dosing/cyclical/frequency has the possibility of changing the dynamic of the toxin in there and safety. Just guessing and like the analyst says, a lot of this phase one is educated guesses. let's hope those big brains can figure it out!
jfm1330 wrote: Glad to see you seem to have more information than me, because part of what you say about better selecting cancer types and patients in better shape was not part of their PR yesterday. So some people sold today without knowing that if true, and still, personally I need to believe your info is true. I am not saying you are inventing it. I just say that I am down to believing somebody on Stockhouse, even if I know he is a big shareholder.
Who told you that? Again, nothing personal, but it would have been much better to hear it from the company. Why are they leaking stuff to some well placed people, and not to the small investor like me? And even if the info would have been directly from them, their credibility level is as low as it can be in my view. Their track record is awful.
SPCEO1 wrote: You said "And now with lower and more frequent dosing, they will aim more at stable diseases than clear objective responses that would allow a fast approval."
Based on what I have heard the company said, this is not what THTX is thnking. It seems they got some mild responses and are looking to tweek the dosing approach and the targeted cancers as wel as the relative health of the patients to get a better response rate. They do not seem very interested in stabilizing the patient's cancer but rather are aiming for a significant impact. So, they are altering the dosing in such a way as to actually get moreTH-1902 into the body than previously by using more frequent dosing of smaller amounts, they are targeting a narrower range of cancers where they believe the hit rate will be more in their favor and are seeking somewhat healthier patients than have taken the drug so far. It sounds like they have learned a thing or two about which patients may not respond well based on previous therapies they have taken and will seek to avoid those.
My impression is they will be putting the new protocol together with the assistance of the trial investigators so hopefully that helps with recruitment once they start up again as the investigators will have been part of the solution. Apparently, another peptide drug conjugate company did similiar alterations to their trial and got better results.