ImetelChat

For my poker playing friends and those students of the tell (Hunt or maybe it was Sargasso this means you). Anyone count the number of times Dr. Scarlett cleared his throat during the last presentation? I did--not many. On a serious note the last update was spectacular. MF R/R continues unchanged and no patients are to be added which means they have enough numbers for a statistically meaningful decision. No further internal reviews are planned so the data will be reviewed on a rolling basis from here on out. They are seeing less spleen reduction than anticipated but have symptom data and lab marker data as well as the hoped for and never previously described longevity. This means to me no phase III for MF will be required and they will present the current data package to FDA this year and will likely be approved for the R/R indication. Earlier stage disease will likely be treated off label if OS is proven so I think there is a serious chance that no MF phase III trial will be required by FDA in light of data measured by above parameters and there is a good chance of early approval. Re MDS also good, very good. Don't expect much at European meetings or even ASCO (but there will be something), the royal flush gets shown at ASH in Dec. All on a finally visible horizon. Also note the wording, "multiple hematological malignancies" this seemed to be in addition to MF and MDS (with AML study soon to come.) Regards and best wishes to all, bp

The Safety Profile continues to be good at all levels. Imetelstat is effective (ET, MF, MDS) and shows promise in combinations (AML & beyond). JNJ has enough data now for full approvals, in addition to the already granted ODD status (FDA & EMA). This is an unique medicine that is needed by patients now.

Biopearl, your use of “spectacular” was not an overstatement imho. The cc was about as good as it could be without including such things like the detail readouts, continuation, NDA, AML CT announcements, etc. I’m not sure why or the considerations of intermediate MDS being left off the MDS trial next steps but Dr. Scarlett, while guarded as always, was very direct and specific in his comments. I don’t remember him seemingly enjoying taking questions as much as on the April 10 cc. BTW, it wasn’t me using the clearing throat count as an indicator of the cards Dr. S. was holding.

For me personally, I was more excited over the coming Imetelstat drug treatment approvals for current and future MF and MDS patients than the investment side. Realizing both will come in due time, but significant revenue streams or a BO are needed to see pps make the big moves up. Short of a near-term BO (not likely in mho), the investment side will likely and understandably gradually follow progress of the developments over the next several months, NDAs and approvals, etc, Dr. S’s conservative commenting style avoiding stirring the investor animal spirits and expected existence of JNJ agreement constraints on information released supports a gradual pps increase once we have “ignition”, which I think we just had on April 10.

I know there is risk with any investment, let alone a biotech without an approved drug. Yet even I as one least knowledgeable on things biotech, believe we who have studied the information and comments provided here and SA, and tried to seriously understand and connect the dots from the cc’s and biotech conferences will have very high confidence in success.

I believe as I think have have explained, given the landscape of many seriously ill and dying patients with minimal or no drug available to help them, the CT results and next steps are coming at us much faster than most are allowing themselves to believe. While I have been critical on the pace of developments to help the most seriously ill, as well as, lack of information on results and strategy, I do believe the path forward for Geron / Imetelstat has been getting progressively clearer and convincing. While always expected, using JNJ/Jansen’s abilities and reputational capital with the FDA, process and strategy to accomplish the entire very complex job of bringing such a product to market in all its possibilities is becoming more apparent.

excerpt post from sdrawkcabeman (YHMB):

'This is the first, unambiguous, concrete statement about Imet’s “approvability.” After the first review, some people were shaken and still wondering about efficacy. This second review puts those doubts to rest. Approaching the FDA with proposals and refinements to Imerge seals the deal for the P3, this is an end-of-study-talk; this isn’t something you do when you lack the data, or when you’re unsure of the potency of the data. It means they see a crystal-clear signal in the data. Let me put a finer point on that. JNJ, with their prestige and expertise, doesn’t approach the FDA w/proposals for an expensive trial(not an academic/IST pilot) w/out seeing the light at the end of the tunnel; like charting a tunnel through a mountainside, you don’t take on that challenge unless you’ve projected the outcome already. This second review demonstrates unequivocally that this is no longer exploratory for Imet in MDS, rather it’s a move towards approval. If the results of Imerge have been congruent to the pilot, as Dr. S has indicated, and they’re booting up the P3, then we can safely assume Imet works just as they thought it would in MDS.'
../..
'The move to P3 in Imerge is literally happening, end-of-study-talks for the P2 have begun. Imbark still needs more data on the R/R pop, we should expect a frontline. This presents a curious circumstance where we could conceivably see a P3 and approval in Imerge BEFORE a continuation decision based on Imbark; again, I allude to section 8.2.1 of the agreement that appears to declare the option of continuation based on any P2/3; think about it... in the case that Imerge gets approval first, Geron would have to decide to opt-in/out to define the revenue structure, yet to do that, JNJ has to affirm the continuation decision, and yet again, to do that JNJ has to move Imbark beyond the P2.'

BP,

You observe:

“For my poker playing friends and those students of the tell (Hunt or maybe it was Sargasso this means you). Anyone count the number of times Dr. Scarlett cleared his throat during the last presentation? I did--not many. On a serious note the last update was spectacular.”

Given the recent news I’m now convinced we read the previous tells correctly. In other words, we got it right. The game has now become quite interesting just as we predicted.

Indeed. bp