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Further thoughts, the good news and the bad news

Posted: Tue Oct 02, 2018 4:31 am
by biopearl123
After several very long walks, sleepless nights, alcohol, and a very painful discussion with my wife, a wonderful woman indeed, I was playing mandolin to try to be with friends and keep my mind occupied, I think we were playing "Cuckoo's Nest", which summarizes how I felt. I then thought of this post by earfool on YMB:
https://www.nature.com/articles/s41591- ... er=www.sta

Here's where I am now in trying like all of us to make sense of the Janssen walk. They have decided to devote resources to the long game and they had to choose. The long game is CAR-t or some other immunotherapy approach. I asked MTB to give an opinion as to how long it might take for a PIII to begin in MDS, he estimates several years. Anyone with familiarity please chime in. I myself have been in company meetings where competing promising technologies are evaluated. And only one won. I believe this is what happened here and Janssen chose CAR=t over Imetelstat. So first the good news: I think the data in both MF and MDS will be very good and they will win the race for product to market. The Janssen walk was not because they didn't like the data, they just liked CAR-t better even though it will be a longer time to market. As you can see there will be serious hurdles with the FDA. The case above involved one cell that carried a malignant gene. One cell. A long time ago I bought heavily into a company that used transgenic goats to make very expensive proteins in a cheap way. The product was pure to one part in a billion. It could not get past the FDA because one virus becomes many just as one malignant cell becomes many. So I think we have a window and Janssen gave it to us like a Hobson's choice while they turn their attention to what may be the holy grail of complete abolition of malignant cells. I hope they succeed. In the meantime I hope we recover. Dr. Scarlett will be able to make a powerful case for Imetelstat once we see the data. Perfection is the enemy of good. We may get good. Janssen is going for perfection. Can't blame them. But I do blame the "shorts" and market manipulators. I can't believe they didn't know about the epic battle between competing therapies in the board rooms of Janssen with the help of some little birdies. And I suspect there is more to that story. You can draw your own conclusions. So far this is the only way I can get the tumblers to click into place in my head. We know the Imetelstat data is good, so did Janssen. We are ahead in the short game and might be ok for a while. It has taken Geron years and years to get here and I have followed all of it. I hope they win the 100 even if the marathon goes to big pharma. There is a window to explore non cellular therapies and combinations as we have seen in AML. By waiting until the last minute and knowing it will take six months to start a study with a CRO Janssen has cut a tendon in our foot. Go get them John. Regards to all, bp

Re: Further thoughts, the good news and the bad news

Posted: Tue Oct 02, 2018 9:19 pm
by earfool
Hello biopearl123

I agree that J&J could very well be prioritizing immunotherapy. J&J also is very much into consumer perception and immunotherapy is more natural sounding….our own bodies fighting cancer with the help of J&J. Certainly, immune systems are better understood than Telomerase Inhibition by the public.

Paradoxically, an advantage of Imetelstat is that the long time development pathway of Geron’s Imetelstat has given much information on any safety concerns and how to recognize and subsequently deal with them.

As you point out, there is long pathway for J&J to travel for to reach a Car-T or other immunotherapy PIII trial. There is still much unrevealed yet about safety issues, long term possibility of relapse to cancer due to cancer stem cells and the side effects of Immunotherapy.

Lastly (posted this morn on ymb)

CAR-T Financial Toxicity

Summarizing the cost literature out there…

When including fees for hospital stays, supportive care, physician visits, other medication and testing…. could drive the total cost of CAR-T to **stratospheric levels** of more than $1,000,000.00
($1 million) per patient. Just the cost of extracting a patient’s T cells, engineering them to produce CARs on the surface of the cells, and infusing the cells back into the patient runs between $373,000 to $475,000.



Best to all ….. earfool

Re: Further thoughts, the good news and the bad news

Posted: Tue Oct 02, 2018 10:55 pm
by biopearl123
Yikes!!