RE:RE:RE:I am a bit bipolar I was struck by how the dialogue with the FDA was characterized on Monday - it seemed like they were working very closely together and that the relationship was very good. I am not sure when the FDA typcially grants a new drug a Breakthrough Therapy designation but I would not be surprised if they got that once the phase I is completed successfully. Based on the data we have seen, which is a small subset of what the FDA likely has seen, it makes sense that the FDA would be very interested in TH-1902.
Also, TH-1904 got hardly any mention and Christian said someting like TH-1902 is pretty much the perfect molecule for what they are attempting to do. I got the impression we will not be hearing much about next versions of TH-1902.
qwerty22 wrote:
It would be interesting to know a bit further about the role the FDA has played in shaping to early part of this program.
I think it would have been equally viable to get PoC from a single indication like TNBC as it would to get it from a basket trial. It struck me from a few things that were said at the KOL event that it has been the FDA that has encouraged the basket trial approach. From the fast track in all solid tumours to the decision to go after all-comers it seems like the FDA want to know the broad applicability of Sortilin. That in some way matches the wider science literature, it's fairly shallow but there is research acrosss a number of cancers and they all tell a very similar story. I know the FDA will always impact the direction a program takes but I'm getting a sense that they have been particularly proactive in making the early stage of the program as broard as possible. Paul emphasized also that going forward that interactions with the FDA would further shape this program.
Paul called them first-in-class and best-in-class, they are really also only-in-class. It's that fact, along with the great preclinical data that's driving fast track and the early shape of this program in my view, encouraged by the FDA.
jfm1330 wrote: After SPCEO1 before, this is the seconf similar message about how a small Canadian company could be behind something potentially big? I understand why one would think that, but at the same time, don't wonder why the stock price is not moving up. The skepticism is even among shareholders!!!
Also, I would add this question to yours: How could it be that FDA gave TH1902 fast track designation while the drug was still at the preclinical stage? I think this is a good question to meditate about...
Contrary to potential investors, FDA had access to the full preclinical data. So there must be a reason why the gave the fast track designation. It does not make it a sure thing, but it surely proves that there are serious reasons to be positive about the outcome.
stockman75 wrote: As I watched the webinar and saw all the impressive pre-clinical results and then after reading all the posts over time from the very knowledgable folks on this message board....
I have concluded I am quite bipolar when it comes to the cancer program. On the one hand it is all quite impressive and seems like there is a high probability there is somehting quite massive in the works.
On the other hand I think to myself how could it be little Thera a small canadian bio-tech could be on to a major advancement in cancer treatment. How could it be Katana sold for next to nothing? How could it be that big pharma did not pick this up? How could it be that it does not get more exposure? The list goes on in the how can it be and I conclude (at that moment of bipolarness) most likely we will not see anywhere near the preclincal results. There has to be a catch..
I know many posts so far have addressed some of these questions/concepts but I still remain bipolar. One moment I think wow this is amazing and exciting. Not just from a potential financial reward perspective but the from the aspect that this is a pretty big breakthough for cancer treatment and what this could mean for people with cancer. and that it all is coming from little bio-tech in canada. Now I know that the wise folks on the science side (and even finance side) say there is much to prove and still considerable risk that it fails in the complex human body. I get that but wow if it works somewhat close to the results in pre-clinical it will be pretty amazing. But again in the back of my mind are all those questions how can this be without anyone seeming to notice except for some people on a public message board and a few institutions. Again bipolar. Am I going crazy?!
By the way thank you to all who have extensive knowledge on the science and finances and contribute so much information. It is truly appreciated and I wish I could add just a small amount of info compared to your frequent and knowledgeable posts. So anyway thank you all even though I know some of you don't want to tolerate the neohphytes who aren't as knowledgeable or scientific minded etc. Yes I have no problem admitting my own ignorance. :-)