Search found 430 matches

by biopearl123
Fri Sep 04, 2020 5:57 am
Forum: ImetelChat
Topic: Orphan being discussed AML/MDS/JMML
Replies: 9
Views: 2114

Re: Orphan being discussed AML/MDS/JMML

rccola335, Thanks for posting this. What is curious to me is why and how the Pediatric committee is doing the reviewing when to my knowledge all of the hematologic studies have been done on patients over the age of 18. The only pediatric study I can remember was related to brain tumors and we know h...
by biopearl123
Thu Sep 03, 2020 5:43 pm
Forum: ImetelChat
Topic: Here’s the relevant patent hat tip to Cheng Ho and Robespierre
Replies: 2
Views: 861

Re: Here’s the relevant patent hat tip to Cheng Ho and Robespierre

Actually Robespierre on SA brought this one to our attention first. Thank you Robes! bp
by biopearl123
Wed Sep 02, 2020 8:45 pm
Forum: ImetelChat
Topic: Hoosier Investor please comment
Replies: 5
Views: 1602

Re: Hoosier Investor please comment

Ryan, perhaps you are right. My primary goal here is to seek the truth where ever it may take us and to foster board discussion. As you know my favorite aphorism is "Surround yourself by those who seek the truth, and run like hell from those who have found it." Perhaps Bill has found it, I don't kno...
by biopearl123
Tue Sep 01, 2020 11:27 pm
Forum: ImetelChat
Topic: Current job listing
Replies: 3
Views: 1038

Re: Current job listing

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
by biopearl123
Tue Sep 01, 2020 11:11 pm
Forum: ImetelChat
Topic: Hoosier Investor please comment
Replies: 5
Views: 1602

Hoosier Investor please comment

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 ...
by biopearl123
Tue Sep 01, 2020 7:40 pm
Forum: ImetelChat
Topic: Current job listing
Replies: 3
Views: 1038

Current job listing

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 ...
by biopearl123
Fri Aug 28, 2020 3:34 pm
Forum: ImetelChat
Topic: Hat tip to Jaime YMB
Replies: 3
Views: 1447

Re: Hat tip to Jaime YMB

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
by biopearl123
Thu Aug 27, 2020 5:45 am
Forum: ImetelChat
Topic: Hat tip to Jaime YMB
Replies: 3
Views: 1447

Hat tip to Jaime YMB

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 ...
by biopearl123
Tue Aug 25, 2020 5:15 pm
Forum: ImetelChat
Topic: From AACR meeting earlier in April/June
Replies: 3
Views: 1435

Re: From AACR meeting earlier in April/June

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
by biopearl123
Tue Aug 25, 2020 4:25 pm
Forum: ImetelChat
Topic: Quote from Dr. Stephen Hahn FDA Commissioner
Replies: 3
Views: 1191

Quote from Dr. Stephen Hahn FDA Commissioner

“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 ...
by biopearl123
Sun Aug 23, 2020 9:19 pm
Forum: ImetelChat
Topic: New discussion topic:provocative by design, have at it
Replies: 5
Views: 1351

Re: New discussion topic:provocative by design, have at it

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...
by biopearl123
Thu Aug 20, 2020 6:42 pm
Forum: ImetelChat
Topic: New discussion topic:provocative by design, have at it
Replies: 5
Views: 1351

New discussion topic:provocative by design, have at it

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...
by biopearl123
Thu Aug 20, 2020 6:15 pm
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2399

Re: Re EU MA

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...
by biopearl123
Thu Aug 20, 2020 6:38 am
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2399

Re: Re EU MA

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...
by biopearl123
Thu Aug 20, 2020 3:34 am
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2399

Re: Re EU MA

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...
by biopearl123
Thu Aug 20, 2020 3:23 am
Forum: ImetelChat
Topic: From AACR meeting earlier in April/June
Replies: 3
Views: 1435

Re: From AACR meeting earlier in April/June

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...
by biopearl123
Sat Aug 15, 2020 6:06 pm
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2399

Re EU MA

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...