RE:RE:RE:RE:RE:RE:Update the time line As I wrote here before, one more reason to hope for convincing efficacy is to facilitate enrollment in phase Ia. We also need to remember that phase Ib will select patients based on sortilin overexpression. If they can have efficacy data in phase Ia corrolatedto sortilin overexpression, than it would be much easier for a patient with confirmed sortilin overexpression to try it. Also, that patients willing to enroll in last chance clinical trials are the most motivated ones and they, or family members or good friends, do searches on the net to find any possible options. So often the demand will often come from the patient through the doctor. An oncologist is not aware of all the clinical trials out there that could be good for one of his patients. So some good efficacy data in phase Ia that would bring more exposure would be a good thing for phase Ib.
Wino115 wrote: I think 1b will be run quite differently. In 1a, there are only 4 study sites enrolling and we must assume a completely untested, unknown, small Canadian bio only known for 2 small HIV drugs is not going to be the first one the oncologist reaches for. That's what they've faced. Given all the trials, it's a competition for enrollment and unknowns fade to the background.
That's where compiling all the data, showing the safety and POC will help the efforts in convincing an oncologist at a study site to try TH1902 over other trials where the sponsor or approach is far more known within the doctor community. It's up to the leads and THTX to get that supportive data out there from 1a and it should help if it's good. If it's average, it won't.
Between a more convincing scientific case and far more study sites they should be able to move quicker. Absent that, they won't get 40 enrolled for many months at best. I hope they and MD Anderson push it based on 1a .
jeffm34 wrote:
Or enrolment has been very slow, which could signal a longer time frame for the phase 1b trial as well. That is a very real possibility. The company could easily put that scenario to rest with a simple update but they've left it to investors to speculate on reasons for the delay
SPCEO1 wrote: Given that they already got to the 420mg level the likelihood of bad news on the MTD is minimal. It is more likely just good news or great news on the MTD. The news we would all like to see is a sign of preliminary efficacy and it is a 50/50 bet on that.
jeffm34 wrote: If the delay in the trial is due to good news, haven't seen any DLT's yet, I'm sure they would announce that. We can only assume now it's bad news. Would also explain the continued downward pressure on the stock price