Cert, Gold, SMC, Lucky, other aliases,
You make some good points. Glad to see you have once again flipped to the side of all things positive regarding IDRA and their long and winding road. You have been highly critical of the steps Milano and group have taken in this long and winding road towards ultimate approval of Tilso. In particular at stops along the way you criticized them for abandoning the bench and 3GA, not picking a partner, taking too long with biopsies, not jumping on the COVID bubble and many more. It is certainly your prerogative to disagree with management but I am glad you now realize that essentially EVERY move that the team made was necessary and in the interest of providing proof of efficacy (one of the most elegant translational studies ever performed and now being copied as standard), proof of safety, anticipating and providing every question that the FDA would have, and focusing on a single agent with the most likely chance of succeeding with limited funds and financing. Perhaps now you understand that these things take time and focus.
With regard to the ORR, north of 30% would be fantastic. I hope you are right. Your zeal needs to be balanced by the fact that even though they are treating less sick more uniform patients there is still a tendency for phase 3 results to be less impressive than phase 2 results. You make good points. Again I hope you are right but the outcome is not a given as you imply.
I agree Dr. Diab is a huge positive in his comments on this drug. In particular his statements about patients taking a one and done medicine and going on with their lives unlike traditional chemo agents that require multiple and never ending rounds of drugs often with bad side effects. Also his emphasis that a new way of thinking in cancer treatment is longevity and survival with good quality of life over survival or cure at the expense of quality of life. The excitement within the oncology community and expansion of clinical sites and the quick enrollment of patients is in large part due to his knowledge and presentation of the translational findings that took TIME and perseverance.
As we approach what is essentially a make it or break it moment for all of us longs and in the survival of the company, it is good to see critics are coming to understand that this was the ONLY path that management could take to get to the point of a successful agent reaching approval.....all indications are that they chose well. Good luck to you. It is good to see that you once again can see the light.