ImetelChat

Very worth a careful read:
https://seekingalpha.com/article/418977 ... imetelstat

Hoosier has presented a very good summary of the possible upside scenarios.

Of course that means he will now be struck down by an unexplainably improbable concentration of cosmic rays. Farewell, Hoosier.

I agree with all the points. It is a foregone conclusion that Janssen will Continue and Geron now has the funds to confidently opt-in

- ET which showed near 100% remission

- Mayo Pilot studies as peer reviewed in NEJM, 'tantamount to a cure' in some cases as stated in Mayo Clinic brochures

- MF trial, which I believe the OS threshold being reached would be a material event which must be disclosed to the public and not just insider information - hence we have that most primary of metrics for patients involved, life - with bigger spleens, still? My take was always was Remissions (clearly taking place and confirming the Mayo Remissions) would eventually lead to a reduction in spleen side and those side effects, since Imet doesn't target the spleen but the cancer itself it would require more time for this secondary (<--- in my opinion) of metrics. Janssen will prioritize life over spleen, I am confident.

- MDS trial, which is showing "safety and efficacy in line" with the tiny Mayo pilot (and Hoosier makes a fantastic point was designed by Janssen), delivering Transfusion Independence. Janssen sent their researchers to Sweden to deliver an Oral presentation, they are not pulling out, they are leaning in...

AML - It still blows my mind that the stunning pre-clinical combo data from ASH 2016 (2016!) was never digested. This kind of efficacy in clinics would be a game changer.

Then Yale study, pan-cancer potential - Janssen does not leave this on the table.
Not to mention a Nobel Prize for the discovery of telomerase over a decade ago now.

And by the way, off topic but not really - AST trials are delivering 90%+ efficacy signals and return of one level of motor function and in many cases (~35%) two levels of motor function. This was the dream of OPC being realized.

The only question I have in re: Continuation Decision is when, not if.
And my only question for today's CC is which of these cards Dr. Scarlett plans to show today. If it's none of the cards and he keeps his poker face, there will be a *lot* of frustrated stockholders at the table and, I'm sure, the saloons!

No cards shown - although I think he is tipping his hand with the second 'derisk' statement and confidence in either decision from Janssen.

(the Decision is yes.)

Ryan, I agree with your points and with Hunt. The conference call was really just treading water. "Derisked", we know we know. Can't say anything until ASH, we know we know. We are ready to go it alone...thank you John we know, we know. So other than the info re the shelf offering there was no new news other than there will be no more dilution until the CD. Well, thats pretty good news anyway. I did think there was a reasonable chance for a CD by now since clearly adequate time for analysis of both studies internally has likely taken place. And it has... If they know that data from both studies will be presented at ASH, they have the data and in truth Janssen knows what they want to do. And there is a good chance the Scarlett aka Columbo also knows. They just aint saying and he has always been understated and deliberately opaque. The strongest piece of information from the CC is that they plan to present data from both studies. They are not going to present negative information. Each year I look for a plenary session from these guys because the data is so ground breaking but maybe this year. So what are they waiting for. Presenting the data does not preclude some meaningful change in drug status with either the FDA or EMA. For competitive reasons, this must be what they are waiting for. In order to have presentations ready to submit by the Aug 1 deadline for ASH they must have done a substantial amount of analysis. Probably enough to know about the CD. Probably enough to know about Phase III in MDS, probably enough to handicap approval. This means that the CD and some change in drug status (maybe not quite to the level of outright approval but some change) will probably happen simultaneously since we did not get the CD yet in spite of all this. We are on a short time frame finally. I recall Dr Scarletts early presentations vividly. He spoke about Phase II data being the inflection point of assessing a company's value. He has a history that suggests this is when he wants to unload. Despite his protestations to the contrary and a plan to go it alone, this is very unlikely given what we know about him. bp

My current theory is that JNJ has applied for accelerated approval for MF based on the primary analysis of IMbark and needs the FDA's decision in order to present GERN with a clinical development plan. In other words, JNJ needs to know if a future registration study is still needed for MF or if IMbark is sufficient (and to a more minor extent, whether to include a Phase 4 study to support the accelerated approval). The clinical development plan would need to identify these paths and associated costs for GERN to decide whether to opt in.

I would not be surprised with a joint announcement of accelerated approval and JNJ's opt-in decision. But perhaps overly wishful thinking.

A postscript:

GERN is confident the continuation decision will be coming in Q3. One way to have such confidence is to know the FDA has a PDUFA decision date prior to September 30, if JNJ has submitted its NDA application. Just thinking out loud.

j6p

So concerning this possible PDUFA date I have a few questions.

I've found that this is the normal procedure:

"Today, at a high level, here is how the process works:

A drug manufacturer submits a New Drug Application (NDA) or supplemental New Drug Application (sNDA) along with the appropriate fee to the FDA. Supplemental applications are submitted when a drug manufacturer wants approval to market an already approved drug for a different use.
The FDA has 60 days to decide if the application is acceptable for review.
If accepted, the FDA then has 10 months to respond (or 6 months for a priority review) with an approval or non-approval or with a 'complete response'.
A complete response basically informs applicants of changes that must be made before an application can be approved."

1) When would JnJ realistically have submitted an NDA to the FDA?
2) They speak of 6 months for the review if they deem it priority, the 60 days are to check if the application is acceptable for review. Are we not expecting BTD or AA too early or is it different in these cases?