ImetelChat

Probably not. Just the slow restoration of sanity.

Not sure if I have this right but Dr. Manero’s quote mentions R/S + as the more common phenotype but my understanding is that only 25% of MDS patients have this phenotype. So I might be coming at this as an undereducated non hematologist. Clarifications appreciated.

Here’s the relevant quote from Dr. Manero: “ Dr. Garcia-Manero said the disproportionate number of patients with ring sideroblasts was the result of the more common occurrence of this phenotype and the approval of luspatercept in ring sideroblast–positive patients. “The study was not powered to see ...

There are a few things that remain unclear to me and I hope CKTC will turn on the search light to illuminate. The COMMANDS data going before the FDA for first line therapy approval certainly “outshines” ESA’s. But in looking at the patient population of 354 patient in the study, 220 had ringed sider...

Kmall, I have to agree. I quick look back to as recently as the June presentation did not guide the delay in MF study (but we knew it anyway and so did they) and also guided something like “ready for launch” in early 2024. These two misrepresentations alone are barf worthy. If they are really planni...

Yes, but unless the FDA chooses to approve sooner (not likely), Geron is forced to carry a very heavy financial load that will not be offset by much from EAP

CKTC, great to see you posting again. It always gives me some measure of reassurance to read and think about your thoughts. A couple of points you brought up worth revisiting. As you point out, COMMANDS 3 and IMerge are not equivalent studies, the former head to head with ESA’s the latter in patient...

Best wishes Ryan, often feel the need for a vacation from (esp YMB) myself. See you on your return.

Kmall, interesting. Durability has always been emphasized by Geron as they “differentiate” from the competition.

I think as the dust settles and we start to get clarity, Luspatercept will probably start as first line therapy, not really a surprise, eventually therapy will fail and patients will move on to Imetelstat. They might even be used in combination, or intermittently after treatment “vacations” no data ...

rccola makes a strong point. All along Geron has made the point that Imetelstat could be used in the R/S negative population (75%) while Luspatercept was not effective. Anil’s presentations emphasized the same points. But here we see priority review for Luspatercept on trial for all MDS subtypes. Wh...

I suspect it will be months before the ADCOM for Imetelstat is convened. I hope they will ask the leaders in the field to sit on that committee. Dr. Rob Califf is the director of the FDA. He is a distinguished cardiologist. Once he hears Geron’s presentation he may be more disposed to realize that 7...

Jay, to clarify: priority review can be granted to NMEs. But a review panel is likely for an NME regardless of standard or priority. Suspect Geron will say FDA is really backed up and having a review board would add time anyway, etc etc.

Ryan, an accurate history to be sure. What news remains for this year? Update on the oral agent by the end of the year? 50% enrollment in MF study? Early Rux/Imetelstat data? Probably not a lot near term to enhance shareholder value except a partner/buyout. There are a lot of new hires on the payroll.

Kmall, presumably the UK “office” is still on the payroll. It’s a mystery. John has some ‘splaining to do. Be interesting to see Geron’s spin on all of this. They will probably emphasize that well its only 4 months difference and approval could come sooner anyway. You sure have to wonder, the FDA se...

Maybe the Europeans will see it differently but in any case we have to live with standard review. Something is a little stinky. Shamefully so. Standard review is still a big deal and we get a drug on the market(eventually) but the uniqueness of Imetelstat has not been recognized by the FDA, it’s jus...

Saltrock, no question Dr. Scarlett was brought in to get the company in shape to sell, especially after Dr. Okarma made such a mess of things and ran up huge amounts of debt. When that didn’t happen in 2018, after years of work Dr. Scarlett could have had a comfortable retirement (just look at the C...

The thing about timing is that the market reacts to events. Many are anticipated such as NDA filing, assignment of priority review, approval (how bout that one) and sales (really, how bout that one too). But what would move the stock the most at least short or near term would be a partnership or acq...

No sh-t

Hi Saltrock and thanks for posting. It basically means they get down to business. The FDA reviews in depth for approval. They decide on priority review (a given with unmet needs and great clinical data) so they will assign an approval date and make that public. During this time the FDA may require a...