ImetelChat

Bill to your point that Geron is not "doing preclinical of their own", several fine academic programs have published preclinical studies as you well know. An unknown is what the CRO has going behind the scenes. We have no idea and it could be a big nothing. bp

HI, as you know Cheng Ho has been very interested in MAIA and posted a link to an article in Cancer Cell. This work is preclinical but Bill feels it is very promising. Since you are the master of IP would you please comment to the extent you can regarding Geron's IP in this area? There does seem to ...

If Geron fills this current job offering for yet another top tier statistician it will mean three full time experts in this field. That's a lot of number crunching. There will probably be a lot of data rolling in from the PIII MDS and MF study but not for some time (although mean onset to effect in ...

Looks like it’s amateur hour all over again. The new job posting has apparently been modified to just say hematologic malignancies. How about a little attention to detail. bp

New Geron job posting: https://www.geron.com/view.cfm/92/director-biometrics-and-clinical-systems Note the new wording change from "hematologic malignancies" to "oncology." Tp me this suggests a preclinical expansion to solid tumors. Emphasis on "suggests". Recall recent odd seemingly anachronistic ...

Here is a better link: https://mct.aacrjournals.org/content/10 ... ement/A137

Looks like the doses in mice have been validated in the early Geron literature:

Utilization of Preclinical Xenograft Data in Predicting Human Imetelstat Target Tissue Concentrations

“I just want to emphasize this point, because I don’t want you to gloss over this number,” he said. “We dream in drug development of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance.” Hahn added: “Many of you know I was a ...

Hi Ryan, I know! But these are probably not top tier hires since the option grants are relatively modest in size and the positions themselves don't warrant a PR. Have always wondered about the "sales and marketing" wording. For a drug that supposedly won't be approved for three or four years at leas...

So if you were any company with a little bit of cash, wouldn't you want to do an exploratory 50-50 partnership with Geron to explore the feasibility of a high risk MDS/ AML treatment? Could be a big return for not too much money (relatively speaking). What about the ethics of withholding a potential...

Exactamente, Lus label is for RS positive, a fraction of the MDS population. Imetelstat has much to offer across the board. Will the EU see it that way? I don't know. The real question all along is whether the EU will value the PII data in both indications enough to allow for MA. It is a stretch bec...

Hi Ashah, Geron has already and correctly I think, rejected the FDA suggestion for a low dose arm as part of the PIII MF study as redundant, unnecessarily costly and of little contributory value in light of what is already known. This is especially relevant since the experts have a good handle on ho...

Kmall, your not so good news scenario might not be so bad. We know for sure the FDA is not going to approve until they see PIII data. (Their recommendation for yet another low dose arm in the MF study is infuriating and suggests they haven't been paying attention.) But we don't know about the EU. It...

Well, its great to see early research in other areas. Be great if there were a clinical application in CML BC which basically heralds the end. I am perplexed by the 30mg/kg, 3x/wk dosing which is basically many fold higher than the 9.4 mg/kg q 3 weeks we are seeing used in MF. Am I looking at this r...

Hi Kmall, have been thinking about your potential timeline to MA in Europe of 67 days. The problem I have is how that could possibly reconcile with enrollment in the ongoing PIII in MDS? If early MA were granted (in my view this is a stretch), the MDS study would not be fully enrolled and patients w...

Hi Martin and Kmall, thanks for posting. I have to agree with Kmall that it is likely that Janssen knew exactly what they were walking away from, at least with regard to MF. I base this on a few things but mostly on knowing that data in the the MF study was evaluated on a "rolling" basis. In other w...

Once in a while Fan on YMB comes up with some interesting information as a result of his or her diligent digging. In this case the following: https://8c3e11d9-5f36-452f-abe3-c95befd6e85d.filesusr.com/ugd/e1a359_3ce53a1d83e84d6d83866c55195d1056.pdf Check out the verbiage under "evidentiary requiremen...

The fact that EU orphan designation has been granted to MDS as anticipated in the PR of early July, this could be viewed as a formality but one I would think that warrants a press release rather than having the minions like us searching data bases to confirm this event. This suggests to me that addi...