14 months since Gernobyl

[biopearl123]

Well its been about 14 months since Gernobyl. Since that time (ignoring the stock price) some very good things have happened. We have a first class management and development team, fast track in two indications, money in the bank, optimistic meetings with the FDA and multiple signals that manufacturing is proceeding apace. A reminder about a few things. Janssen had us on the billion dollar list for the MF indication. Recall that the agreement with Janssen was just for MF not MDS. The MF study was looking for very hard to find end points e.g. spleen and symptom reduction in patients who has already had spleen and symptom reduction from Rux and relapsed. We still don't know what things would have looked like had Imetelstat been used front line in the same way Rux was. The patients in the R/R study were very much more advanced. None the less there were still endpoints of meaning especially with the dramatic MOS improvement. KOL meeting resulted in public presentations. The FDA is legitimizing RWD as a control arm and no matter what the next study looks like, having a classic control group presents ethical issues and would hamper further study. Rux does not appear to result in disease modification, Imetelstat may. The MDS study while on an apparently longer timeline will have 90 sites and should enroll pretty rapidly. We have some impressive 24 week TI's so far. The potential for reaching the primary endpoint before the study completion date is possible. As 2019 closes I wanted to wish the board a happy and hopeful new year! bp

[cheng_ho]

Janssen was clearly concerned with MDS from the beginning:

https://ir.geron.com/investors/press-re ... fault.aspx

You can't un-GERNobyl a reactor, you have to build a better one... hopefully with a negative void coefficient

[signet01]

" Recall that the agreement with Janssen was just for MF not MDS."

bp, If I'm not mistaken I believe the deal gave Janssen the rights to develop Imet for "all human indications"...
I remember thinking that the deal was "overbroad" for a drug with such potential to be "disease modifying"...
My continued thanks for your reasoned input and for moderating this site...

[biopearl123]

Signet 01, you are quite correct, but the CD was to be based largely on the MF data if I remember correctly. Later Scarlett said Janssen would also take the MDS data into consideration before making a final decision. Regards, bp