Why I think April is a possibility

[biopearl]

I have been asked in a different forum why I made a comment that April may be the time for data release. Its just a guess but consider this. The September surprise was Sept 12th or so I think. At that time enrollment stopped and at least 20 patients had made it to 12 week mark in the high dose group for eval by that time. If the remaining last enrolled patient of the purported 40-60 total patients (excluding the low dose group) was enrolled the day before (for the sake of argument) than the last patient had 24 weeks in the study as of March 12th. If the primary end point remains spleen/symptoms surely a read out on the last patient will not take more than an additional three weeks, which brings us to April. Of course more complex end points are also being looked at e.g. molecular response etc which might take more time but to determine if the study goes forward or stops or is modified, if the end point of spleen and symptoms are ascendent than that data should be completely available by April. Hence my supposition. Remember the data analysis is rolling, such that each patient is analyzed for primary end point as soon as he or she reaches 24 weeks on drug. These means only a few patient remain to be analyzed at the March 12th mark. Also the proportion of original 20 that did not reach the 12 week predetermined super secret metric may have reached it by 24 weeks if indeed all that is needed is tincture of time, per Dr. S opaque comments, to achieve. So some decision in that time frame seems reasonable. One last point. The recent 8k slides suggest that the 24 week data is to be analyzed to confirm proper drug DOSE not to evaluate DRUG EFFECT (this implies to me that drug effect is a given). I think that's important. Any thoughts? Have at it Ligas! Regards to all, (has anyone heard from Irish?), Regards, bp

[jayfish101]

Thanks, BP for your thoughts. I have all along felt there is a good chance for a six month (from the Sept review) review. I am interested in your comment that there is a rolling/ongoing review of each patient as they meet the time requirements. Where did you get that?

[biopearl]

One more point: If we are receiving honest information several "unprecedented" CR's and PR's (not to mention CI's) are out there right now. (Mayo data plus J and J--I am presuming some effect in the J and J population which admittedly is an unknown but the study continues so there must be something even if its spleen and symptoms). Right now as in right now. Given that durability has been emphasized, then I really really have to wonder how the study can continue from an ethical standpoint. Come on Data Monitoring and Safety Commitee--call it already. Remember the ethical responsibility you have, unprecedented means unprecedented. Durable means durable. Don't have good data yet? Ok then continue the study. That's the only way you could justify it, and for us it means we have to be wary of the purported efficacy of the drug--this seems unlikely. And FDA can you EVER make up for delaying this medication in the face of ongoing expert hematology and hepatology panel review the way you did? Maybe start with immediate approval now and save a some lives and stop being complete tools. bp

[sargasso]

BP,

GERN states that it will supply to the FDA all of the clinical data it has at the end of Q2, 2017. I am in the habit of asking simple (simplistic, simple-minded?) questions on this board so I will ask another:

What is the purpose of this submission? What does GERN wish the FDA to do w/ this information?

[biopearl]

Sargasso, I know Fish mentioned this too which would be a good sign I think. I just can't place the source of this info, can you or Fish provide a link or a source? Thanks, bp

[biopearl]

For Jayfish: From Anna. bp

[sargasso]

BP,

I just listened again to part of this presentation:


Title Q3 2016 Geron Earnings Conference Call
Date and Time Thursday, November 3, 2016 1:30 p.m. PT

Scarlett states at least twice in this conference call that GERN/Janssen intend to submit data to the FDA at the end of the 2nd quarter, 2017. He states this, however, or alludes to this in a sort of vague, indefinite and confusing way, or at least during the part of the conference call I listened to today. At one point, in answer to a question from an analyst, he confirms they plan to make such a “regulatory submission” but then states he will not discuss the matter further. All of this comes fairly early in the conference call.

[biopearl]

Thank you. bp

[Fishermangents]

Thanks, Sargasso, for looking up this important remark. I remember that he said that JnJ was going to present the data of the full imetelstat program. That could mean all they know about imetelstat from IMbark, IMerge, Mayo trial and whatever they learned from the numerous pre-clinical studies they have sponsored / are sponsoring and are willing/able to share with the FDA. I am not 100% sure how to interpret it. But as Dr.S. announced this already some time ago I can imagine this is part of a 'masterplan'. It is also difficult to imagine that, while Dr.S has announced this at a stage while the trials are still running, they expect these data to be bad. Why else announce it and why are the trials still running? I will be careful with conclusions, but I consider it as a positive signal. Off course we will only know once this meeting took place, if at all.

[biotech_bs]

Sargasso, Thanks for listening again. I can't imagine that they would be talking about putting together a collection of Imetelstat data to present to the FDA if it was negative in any way. If the data did not support going forward I believe Janssen wouldn't be putting together a collection of data to present to the FDA. If they made a negative continuation decision they would just announce that the trail(s) did not meet the primary end and .... adios .. we are done with Imetelstat.

[sargasso]

Fisher and biotech-bs,

I agree w/ your observations. There would be no point in sharing this data w/ the FDA if all it contained was negative information. I see this planned submission as a positive development.

[biotech_bs]

I did go back and listen to the Q3 CC.

Chip said that the decision by Janssen to proceed with Imet in MDS would be decided by 3 factors

1) 2nd Data review of patients in part 1of IMerge in 2Q
2) Data from the Imet program overall
3) "regulatory review"

Provided the criteria is met they will proceed to the blinded phase 3 portion (or part 2) of the MDS/IMerge study.

In the Q&A Chip was asked about what "regulatory review" means. He said that it means to submit the data to a regulator. The analyst then followed up by asking if this means that you would be waiting to hear back from the FDA before proceeding. Chip responded by saying he would not comment further about "regulatory review" (not using the term FDA). The light bulb went off in my head after this. Chip explicitly used the term "regulator" and the analyst was the one saying "FDA". This leads me to think that perhaps Janssen will begin the EMA approval process before seeking FDA approval as has been hinted at by posters on other message boards based on various EMA proceedings that have taken place. If you want to draw your own conclusions start listening at about minute 17 in the Q3 conf call

[Fishermangents]

Very interesting observation, biotech!

[sargasso]

biotech-bs,

That is an interesting speculation. It did not occur to me that Scarlett might be referring to the EMA.

[sargasso]

I have been thinking again about Scarlett’s statement during the Q3 CC that they plan to make a “regulatory submission” at the end of the second quarter, 2017. I find that statement intriguing. It seems fairly obvious Scarlett would not make this public announcement unless he already has data that will be viewed favorably by a regulatory agency. So what is this data and what does Scarlett know that we as yet do not know? It seems to me this public statement about a regulatory submission may be a fairly significant tell. “A tell in poker is a change in a player's behavior or demeanor that is claimed by some to give clues to that player's assessment of their hand.”

[biotech_bs]

sargasso,

I agree that it seems significant. If Janssen was not going to make a positive continuation decision they wouldn't bother with a data submission which includes all Imet treated patients over the years. I've tried to contemplate why they would do this. Thoughts that come to my mind are:

- to establish criteria/end points with the FDA for a pivotal phase 3 study ?
- Break through designatoin ?
- Early European approval ?

In my tea leaf reading I continue to think about an analyss that twice said the FDA and Chip responded by saying "regulatory agency" without specifying the FDA

[biopearl]

Hi Sargasso, hmm, a poker player... The real tell was when Scarlett said at the beginning: "this may be bigger than all of us". But a poker player would look hard to see if this was a "tell" or a set up for a "sting". They look the same and a good poker player makes them look exactly the same, and Scarlett is a good poker player. Well will know soon enough, he knows how to make one stay in for the last round of bets. bp

[Fishermangents]

Dr.S. said that data of the 'full imetelstat program' were to be submitted to a regulatory body. The question is what is included in this program according to JnJ? Also recall that JnJ is sponsoring numerous research studies on imetelstat and that there is quite a large source of information from old trials that have been discontinued. Those trials were performed by Geron, so I guess that those data have been made available to JnJ also, just like the Mayo data.

The purpose of this early announced meeting can be manifold. One could be the establishment of a master plan, another could be indeed a move to P3 with IMbark and/or IMerge. Maybe a new trial is being designed or a request for fast track is being submitted.

I don't think this meeting will be about bad data. Why should they have this meeting and then tell that everything goes badly and should be stopped? They can stop everything right now, also without such meeting. How bad can it be, when IMerge goes forward according to expectations? It is more likely to think that the basic message will be positive and that they would like to show their strategy to the FDA or EMA (or another regulatory body) to make sure they can safely progress with whatever plan they have.

Off course: I believe it when I see it...

[biopearl]

Odds are the meeting will be about BAT for MF and MDS. bp

[sargasso]

BP,

Ha! Very good, bp!

You raise the interesting possibility that Scarlett has engaged in a fake tell in order to keep players sitting at the table:

“When a player fakes a tell, he is deliberately displaying it to get the attention of the observant opponents who are looking for tells. Fake tells are meant to mislead the opponents, and can be a great weapon in a poker player’s arsenal provided they are used the right way. A fake tell, also referred to as a reverse tell, can be used at any time during the game, whenever your opponents think that they have identified your tells.” https://www.gambling.com/online-poker/k ... -tell-2900

The problem is I don’t think Scarlett particularly cares at the moment who walks away from the table (who remains long the stock) since at the end of the day he makes the same amount of money no matter who the players are, if he wins his bet on GERN. In addition, it is more likely than not that what Scarlett wishes to establish at this point in the game is credibility and not the opposite assuming, of course, he is not a complete Charlatan. I am therefore betting Scarlett has issued a tell.

So ends my poker analogies.