RE:RE:Legal counsel medical affairs We know very little about what actually has gone on in the phase 1a, other than it has taken an unusally long period of time to complete. My guess now is there was some uncertainty for a time about some aspect of the trial, thus the length of the trial, the corporate presentation being pulled down for a bit and the lack of updates. When Paul gave an update in October and then said no more updates until the trial is over, that likely was a sign that they had hit some sort of speedbump at that point (and it coincided with Paul reporting on the first 420mg patient encountering some issues). That is also when Dr. Rothenberg was brought on - maybe he saved the day for us by helping TH navigate whatever the issue was at the time? All that to say that perhaps TH did not have the certainty that all was good to go with TH-1902 until more recently and thus was not about to hire this lawyer then. There were no lawyers needed because there were no deals needing to be worked on until they resolved whatever issue that may have been a stumbling block earlier. With all that, whatever it may have been, apparently sorted now, they are ready to move forward and now need the legal help. And whatever the issue was, it also did not stop TH from making other hires so perhaps the long trial delays were not so consequential scientifically and more just normal testing nonsense the company had to navigate. There are a lot of egos to manage in a clinical trial and only one getting carried away on something minor can cause a lot of trouble.
You will notice the job description does not talk about negotiating partnership deals but the more mundane stuff like agreements with clinical trial partners. But the partnership deals are likely going to be the job of TH's lead lawyer and perhaps they are just looking for someone to take the more basic stuff off his plate so he can focus on the more critical legal matters. It certainly feels like that type of hire to me.
Whatever the real explanation might be for the long delay in completeing the phase 1a might be, this is just another of several positive signs pointing towards a hopeful future for TH-1902. It has a long way to go but it looks like it has successfully cleared the very important first hurdle. What we don't know is how far above the bar it cleared that hurdle. Is the hurdle still vibrating because they hit it on the way over, did they just manage to clear it without hitting it, or did they clear it easily? Hopefully, they will give us enough data on the phase 1a to determine how easily the hurdle was cleared. Still, we can be super confident it has been cleared and TH-1902 is moving ahead to face its next challenge. Moreover, we may well know fairly soon if it has cleared that next challenge in phase 1b which will be signs of preliminary efficacy significant enough for TH to rush to the FDA with a request to start a phase 2 trial on one of the cancer types they are investigating.
Phase 1a was ponderously slow but there is a chance TH could be in a phase 2 cancer trial in the not to distant future. In a possible best case scenario, they quickly see preliminary signs of efficacy in at least one cancer type by mid-Summer, then start a phase 2 by late Summer/early Fall and start getting positive results from that before year-end. Since this is a drug trial, which are notorious for being slow and difficult, it will not likely work out that pleasantly or quickly. But it sure would be nice if they made up some of the lost time from thephase 1a trial.
palinc2000 wrote: This new position quite revealing with regards to intent for the path forward.......However I am a bit perplexed with the timing....I would have thought that the need would be now rather than in a few months