1. How many patients do we think are still at MAYO? It was 45 before the hold, so maybe 30?
2. What does MC need to collect to send to FDA? Remember that Scarlet said it wasn't done yet. Why not? Is there a reason it is taking so long? Does Dr. Tefferi need to track info for months?
3, Please no more talk of mismanagement. We have heard it, too many times, understand your frustration, please stop ringing that bell. Black? ok? or it will be ignore for good. Trying to understand the issues, not listen to constant complaints.
4. Why are we now looking at Jan-Mar 15? Why does it take an extra 6-9 months? If everything was going along as planned - as per Irish, why is it now an extra 6-9 months???
5.Why are people saying the hold will be released in a week or month when Chip said 6-9 months? Why is there such a HUGE difference in time expectancies? I hear optimism from many, but the company says "eariest is 1Q of 2015"? WHY???
6. Any extra info from KNOWLEDGEABLE people, Irish, End, Bio Ptennis?? Where are you guys?
How many are still in the trials you ask?
Reported Drop outs:
---By the October cut off for ASH, 2 reported deaths, 89% of the first 22 were deriving some benefit
--At the January SEC filing -- 20 patients out of 79, ie 25%
---At May 1 CC update -- 14 more patients out of 59 ie 24% more.
My Tentative Conclusions:
1. MC told GERN that there were 45 remaining in the trials sometime after March 20 (WHEN this occurred is not know, but important);
2. By May 1, GERN did not learn of any other drop outs (or Scarlett's limited disclosure of 45 would be considered misleading);
3. Because there was an ongoing process to weed patients out of the trials, probably all 45 were thought to be deriving a benefit at March 20.
4. Some of the 34 that dropped out by March 20 probably were deriving benefits, but decided to leave the trials anyway so it probably is not correct to assume only 45 were receiving benefits from Imetelstat out of the 79..
5. The MC would have informed GERN if there have been any further significant culling out from the 45 (for not receiving benefits) at the same time they told GERN of the 45 (otherwise this figure 45 figure would be misleading);
6. After March 30, there could have been some deaths in the short lived AML and/or MDS groups, but it does not appear that Scarlett was not informed of any.
7. When Tefferi delivers his information to the FDA and GERN, it is going to include how many remain on trial, and what benefits he thinks they are obtaining from Imetelstat, so GERN probably will at least release another update of how many remain in the trials.
8. It is really hard to know how many of the 45 may have dropped out in the 52 days since March 20, but it is reasonable to believe there has been some attrition. I would guess somewhere between 3 and 11 more have dropped. (11 would be another 24%)
Ryan, based on what I think we have been told, here is a more optimistic assessment of those that remain in trials:
1. Assume the MC enrolled the 18 AML and MDS patients last and that in January, when they reported 20 had left the trials, assume none of them were from the AML or MDS group because it was too soon for them to be dropping out after just being enrolled;
2. Therefor, assume the initial attrition was mainly or entirely from the MF patients that either did not get a benefit or otherwise decided to drop out anyway.
3. Since 5 of the first 22 MF patients obtained a remission, that would suggest that at most 1 or 2 of the blast phase AML patients would have a remission (and that would be a great success) so it is likely that at least 7 or 8 of the AML patients have died or otherwise dropped out of the trials.
4. Because Scarlett indicated that the MC was having some success with the MDS patients and GERN was planning to institute its MDS trials before its AML trials, assume that 3 of that cohort are still alive and on the trials.
5. That would mean that of the 14 new drop outs reported in the 5/1 CC, most or all came from the AML and MDS group and that the rate of attrition from the MF group was small because, similar to ASH, almost all of them were getting either primary benefits of CR, PRs or CRs, or at least secondary benefits and suppose this is true of all 61 that ultimately were enrolled.
6. to the extent this could be correct, then there is very little additional attrition from the MF group and maybe 40 still remaining in the trials from that group.
7. Add to that 1 or 2 successful patients with AML and maybe 3 successful patients with MDS and then you would have the makings of a really good efficacy result in all three indications!!
If this latter distribution of the drop outs is accurate, and if these guesses are correct, GERN could become a first line treatment from some of the MF, AML and MDS patients and gain a $10 B market cap!!
ryan: go ahead and put me on IGNORE.
One of the profound issues that each and every long is facing IS GERN management. Like it or not, they are inept and just don't seem to have the right stuff to get Imetelstat to market.
Stick your head in the sand if you must!!!
Imetelstat development needs professional help and that's not chippy.
I sincerely hope that we get it before its too late.
Of course, IMO.
It's perhaps not just Scarlett, it's the entire board along with him that haven't shown any teeth. I wonder where the company and Imetelstat would have been without Tefferi and Mayo!! They screwed up all solid-tumor trials, the ET/PV trials and also the stem-cell future along with our hundreds of millions of dollars of investment being thrown into the gutter!! And, yet, Scarlett is not ashamed of squeezing $2.3M in annual compensation!! Then, trying to know how many patients are still on and off the Mayo trial, to me, is just a worthless effort as a shareholder while ignoring the real culprit.
I'll give it a shot
2. "In its written notification to the investigator, the FDA cited the reason for the partial clinical hold was that a safety signal of hepatotoxicity had been identified in clinical trials of imetelstat, and that it is not known if this hepatotoxicity is reversible. In order to resolve the partial clinical hold on the Myelofibrosis IST, the investigator is required to provide to the FDA follow-up information regarding reversibility of hepatotoxicity for all patients who received imetelstat in the Myelofibrosis IST. For patients who did not experience any abnormality in liver function tests (LFTs), LFT follow-up until 30 days from the last imetelstat dose must be obtained. For patients who experienced any abnormality in LFTs, follow-up LFTs must be obtained until resolution to baseline or normal range for at least two consecutive determinations. Dr. Tefferi has informed Geron that he plans to work diligently to seek release of the partial clinical hold."
So it should be done or nearly done
4. Great question and I had a similar question. Maybe the trial details need to be rewritten? Maybe the data will take longer to collect?
My personal opinion is it is more likely to be 4thQ of 2014, but due to lawsuits, Scarlett needs to be very conservative in every comment he makes.
5. That is similar to Question 4. I think there will be a progression of releases, First, we get a release of Mayo IST (soon), followed by Partial release/hold of Geron (allowing PH2 to start) maybe in 3-4 months, followed by full release for Geron 5-6 months