Scarlett has made clear that Janssen is presently not sharing clinical trial information with him or with anyone at GERN. That is what Scarlett is stating below, correct?
Charles Duncan
“Yes. So your team is involved I know to some extent but I'm wondering if your team has ongoing interaction with investigators and if so, what the recent feedback has been on - from investigators not necessarily on patient disposition because I know you really can't provide much information and investigators probably can't either but really on the imetelstat value proposition and mechanism of action what's your sense of that?
John Scarlett
"So first of all we do not have specified what we don't have investigator interaction. Janssen's really responsible for all of the activities of the clinical trials. So we really don’t have those interactions.”
http://seekingalpha.com/article/4051253 ... art=single
But not long ago, in the conference call before the present one Scarlett announced they will be making a “regulatory submission” at the end of 2Q, 2017. If Scarlett is not privy to the data now being generated by the clinical trials, what data did Scarlett have in his possession to support a regulatory submission at the time he made this announcement?
Confusing
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Re: Confusing
Follow-up questions:
Why did Scarlett make this “regulatory submission” announcement in the first place?
Why was the announcement made prior to the collection and analysis of the trial data by Janssen?
Why did Janssen allow Scarlett to make this announcement at the time he made it?
Assumption: no CEO of a small biopharmaceutical company with one product would make such an announcement lightly since the entire endeavor depends on regulatory approval. In other words, nothing could be of greater interest to shareholders than some sort of regulatory submission.
Why did Scarlett make this “regulatory submission” announcement in the first place?
Why was the announcement made prior to the collection and analysis of the trial data by Janssen?
Why did Janssen allow Scarlett to make this announcement at the time he made it?
Assumption: no CEO of a small biopharmaceutical company with one product would make such an announcement lightly since the entire endeavor depends on regulatory approval. In other words, nothing could be of greater interest to shareholders than some sort of regulatory submission.
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Fishermangents
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Re: Confusing
Sargasso, thanks for these relevant questions. Scarlett indeed announced some time ago that JnJ (not Geron!) was going to present the results of Imbark, IMerge and all other data from the full imetelstat program to a regulatory authority (FDA, EMA,...). Btw: this is not about submission for approval or something like that. Such an announcement is interesting indeed, as obviously 1) it was already known at that time that JnJ would do such a thing (which was well before the review started in Q1) and 2) JnJ did allow Scarlett to speak about it publicly.
In later discussions at became clear (at least for me) that JnJ will use this presentation to present all those data (and probably also their opinion on how to proceed) AND to get feedback from the authority. So in my opinon JnJ will present a plan for imetelstat and they want to know if the regulative authority will support it or otherwise has any comments that may be important to further design of trials, NDA, fast track etc., whatever JnJ has in mind. From the 10-K:
"We expect Janssen's decision-making regarding IMbark, IMerge, the imetelstat program or the Collaboration Agreement to occur in the second quarter of 2017. Janssen's decisions regarding future development plans for imetelstat, if any, may be subject to subsequent regulatory feedback."
The early announcement of this presentation tells me that JnJ has plans to proceed with imetelstat based on the data they already had after the first interim review back in September 2016. If not: why would they invest in such a presentation and let Scarlett announce it at an early stage (and repeating it since) to finally tell the FDA that it all doesn't work and that we should forget about telomerase inhibiton? In that case they just can stop the trials and walk away. They probably let Scarlett announce it because Scarlett urged JnJ to release some information that should inform GERN investors at least for a bit.
"not privy to the data": first, there are things Scarlett formally knows and things that he informally knows. He certainly can't say a word about the things he informally knows. But he also can't speak of the many things he does formally know. In addition, we have the information game between GERN and JNJ, which is a real balancing act for both parties, but mainly for Scarlett. There is sensitive info regarding competition and there is info that is important for the upcoming negotiations between GERN and JNJ, e.g. if there will be some kind of buy out. So GERN and JNJ are 'friends', but also need to keep their negotiation positions. I find Scarlet's answer on the interactions a bit vague. We will probably never find out what information actually is being exchanged between those parties.
In later discussions at became clear (at least for me) that JnJ will use this presentation to present all those data (and probably also their opinion on how to proceed) AND to get feedback from the authority. So in my opinon JnJ will present a plan for imetelstat and they want to know if the regulative authority will support it or otherwise has any comments that may be important to further design of trials, NDA, fast track etc., whatever JnJ has in mind. From the 10-K:
"We expect Janssen's decision-making regarding IMbark, IMerge, the imetelstat program or the Collaboration Agreement to occur in the second quarter of 2017. Janssen's decisions regarding future development plans for imetelstat, if any, may be subject to subsequent regulatory feedback."
The early announcement of this presentation tells me that JnJ has plans to proceed with imetelstat based on the data they already had after the first interim review back in September 2016. If not: why would they invest in such a presentation and let Scarlett announce it at an early stage (and repeating it since) to finally tell the FDA that it all doesn't work and that we should forget about telomerase inhibiton? In that case they just can stop the trials and walk away. They probably let Scarlett announce it because Scarlett urged JnJ to release some information that should inform GERN investors at least for a bit.
"not privy to the data": first, there are things Scarlett formally knows and things that he informally knows. He certainly can't say a word about the things he informally knows. But he also can't speak of the many things he does formally know. In addition, we have the information game between GERN and JNJ, which is a real balancing act for both parties, but mainly for Scarlett. There is sensitive info regarding competition and there is info that is important for the upcoming negotiations between GERN and JNJ, e.g. if there will be some kind of buy out. So GERN and JNJ are 'friends', but also need to keep their negotiation positions. I find Scarlet's answer on the interactions a bit vague. We will probably never find out what information actually is being exchanged between those parties.
Re: Confusing
Fisher,
Thanks for your excellent reply to my posts.
You observe:
“The early announcement of this presentation tells me that JnJ has plans to proceed with imetelstat based on the data they already had after the first interim review back in September 2016.”
That is exactly the conclusion I reached in pondering my own questions. In other words, I think GERN/Janssen is exhibiting a fairly high degree of confidence in IMET. No other conclusion makes much sense to me.
Thanks for your excellent reply to my posts.
You observe:
“The early announcement of this presentation tells me that JnJ has plans to proceed with imetelstat based on the data they already had after the first interim review back in September 2016.”
That is exactly the conclusion I reached in pondering my own questions. In other words, I think GERN/Janssen is exhibiting a fairly high degree of confidence in IMET. No other conclusion makes much sense to me.