Thoughts on Aug 3 conference call
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Thoughts on Aug 3 conference call
Scarlett once said he wasn't trying to be coy. Well he is. Coy, opaque, vague, and infuriating. Its one thing to hold information for competitive reasons but this! I am referring to the deliberate withholding of data from the pilot study. Or is it withheld? If one looks on the CT site the pilot study appears to plan top line data for May 2017 and final data May 2018 (with recent "updates" to the CT site). If the CR and PR high risk patients (six month life expectancy before imetelstat) were dead, the study would be over. And we as shareholders should be apprised. That the study continues implies that some of these patients are alive (median survival of 18 months as of Dec 2014). The disappearance of Irish implies (to me) that John is still on study. If so a dramatic improvement in overall survival may be ongoing. Is it? Only the Scarlett Shadow knows... It is good news that the all the preliminary arms of each J and J study are full. What Scarlett didn't say (again) it that there is one more option after the preliminary analysis is completed in Imbark and that is drug approval based on overwhelming evidence for drug effect. Maybe that's why the additional evaluation at 24 weeks. That would be a lot to hope for. bp
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Fishermangents
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Re: Thoughts on Aug 3 conference call
As long there is no bad news I keep confident. Two things from the call:
- confirmation of the 30 and 40 enrolment completion: that is important indeed, because we now we can start counting the days, although we don't know when exactly the enrolment was completed. It can be added as a fact to the List of Geron Achievements.
- he said that other companies showed interest to imetelstat: that is very intriguing. Why would he say that? It is sensitive towards JnJ and shows confidence. It can be the upbeat for some kind of negotiation. There is more going on behind the screens than we can imagine.
'drug approval based on overwhelming evidence': there is a task for the DMC. But then we speak about IMerge/MDS.
- confirmation of the 30 and 40 enrolment completion: that is important indeed, because we now we can start counting the days, although we don't know when exactly the enrolment was completed. It can be added as a fact to the List of Geron Achievements.
- he said that other companies showed interest to imetelstat: that is very intriguing. Why would he say that? It is sensitive towards JnJ and shows confidence. It can be the upbeat for some kind of negotiation. There is more going on behind the screens than we can imagine.
'drug approval based on overwhelming evidence': there is a task for the DMC. But then we speak about IMerge/MDS.
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Fishermangents
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Re: Thoughts on Aug 3 conference call
AML
I checked the Q2 telco again and at the end Dr.Scarlet said that regarding AML there were no upates. So he reiterated wat has said about that earlier. So no change of plan. Off course it is now clear that it won't be single a agent trial but a combo. He said that at the Mayo trial they gave some blast phase MF/secondary AML patients imetelstat (interesting info!). Although it did show anti leukemic effects (white counts down, blast counts down), it was not sufficient to stop this highly devastating disease and that more was needed (i.e. combination therapy). Which combination is still under pre-clinical investigation.
ASH
He said that there won't be a submission for a clincical report, but they intended to submit 'one or more' pre-clinical abstracts, e.g. one about AML. Would be interesting who will present it.
Acquisition
This seems to be pretty far away and isn't on his radar. So I think we can give that a rest.
I checked the Q2 telco again and at the end Dr.Scarlet said that regarding AML there were no upates. So he reiterated wat has said about that earlier. So no change of plan. Off course it is now clear that it won't be single a agent trial but a combo. He said that at the Mayo trial they gave some blast phase MF/secondary AML patients imetelstat (interesting info!). Although it did show anti leukemic effects (white counts down, blast counts down), it was not sufficient to stop this highly devastating disease and that more was needed (i.e. combination therapy). Which combination is still under pre-clinical investigation.
ASH
He said that there won't be a submission for a clincical report, but they intended to submit 'one or more' pre-clinical abstracts, e.g. one about AML. Would be interesting who will present it.
Acquisition
This seems to be pretty far away and isn't on his radar. So I think we can give that a rest.
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Fishermangents
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Re: Thoughts on Aug 3 conference call
Here a post from Sdrawkcabeman (Yahoo MB, yesterday):
Some thoughts on the call. I hope no one was expecting anything new, since we’ve all known the next development was going to be after the internal reviews. Dr. S was reticent as always but keep in mind that Janssen is the sponsor for all relevant trials. So if Janssen isn’t talking, I don’t think we can expect Dr. S to be talking. That’s the price of a partnership, not that Dr. S has really been forthcoming with info prior to the partnership, though. And remember, the ambulance chasers aren’t an imaginary threat.
Of the crumbs Dr. S did throw our way, to the question about ASH, he said Janssen had sponsored other myeloid preclinicals; I take that to mean any combination of AML, CML, MM; but not excluding a follow up to the Yale study, since the question was only in regards to ASH. And JNJ isn't sponsoring preclinicals to make a splash academically; the preclinicals will reveal JNJ's future map of commercial interests.
And of Dr. S’s response that all MF CRs were ongoing as of Dec 2014, some are still treating (deliberately) the pilot results as a fluke, despite the deep response that’s already been established in ET, MF, and the transfusion independence in the small MDS cohort. From the 2015 ASH slides, there were 2 V617F ET pts who CR’ed for more than 24 months and ongoing. This broad and deep activity obviously isn’t a fluke. As regards the CRs in MF, fibrosis is the signal of myeloproliferation, so those pts who CR’ed, bone marrow and molecular signature, should intuitively have a very strong duration. Don’t forget, these results are unprecedented, and the trial is in context of pts R/R to Rux; that’s paramount b/c R/R pts have no alternative, especially when that “alternative” delivers CRs and the first-line Rux doesn’t. The misinformation campaign can make up whatever they want, but they can’t take away the cold, hard science.
Lastly, JNJ disclosed intent to file in 2017; this is only possible through an expedited approval process. The corollary is that JNJ must elect to continue, make milestone payments, and set a cost split for further trials at 20/80 GERN/JNJ. This all hinges on the internal reviews, slated before the end of this year. So despite the reticence, we will have plenty of developments announced shortly.
Some thoughts on the call. I hope no one was expecting anything new, since we’ve all known the next development was going to be after the internal reviews. Dr. S was reticent as always but keep in mind that Janssen is the sponsor for all relevant trials. So if Janssen isn’t talking, I don’t think we can expect Dr. S to be talking. That’s the price of a partnership, not that Dr. S has really been forthcoming with info prior to the partnership, though. And remember, the ambulance chasers aren’t an imaginary threat.
Of the crumbs Dr. S did throw our way, to the question about ASH, he said Janssen had sponsored other myeloid preclinicals; I take that to mean any combination of AML, CML, MM; but not excluding a follow up to the Yale study, since the question was only in regards to ASH. And JNJ isn't sponsoring preclinicals to make a splash academically; the preclinicals will reveal JNJ's future map of commercial interests.
And of Dr. S’s response that all MF CRs were ongoing as of Dec 2014, some are still treating (deliberately) the pilot results as a fluke, despite the deep response that’s already been established in ET, MF, and the transfusion independence in the small MDS cohort. From the 2015 ASH slides, there were 2 V617F ET pts who CR’ed for more than 24 months and ongoing. This broad and deep activity obviously isn’t a fluke. As regards the CRs in MF, fibrosis is the signal of myeloproliferation, so those pts who CR’ed, bone marrow and molecular signature, should intuitively have a very strong duration. Don’t forget, these results are unprecedented, and the trial is in context of pts R/R to Rux; that’s paramount b/c R/R pts have no alternative, especially when that “alternative” delivers CRs and the first-line Rux doesn’t. The misinformation campaign can make up whatever they want, but they can’t take away the cold, hard science.
Lastly, JNJ disclosed intent to file in 2017; this is only possible through an expedited approval process. The corollary is that JNJ must elect to continue, make milestone payments, and set a cost split for further trials at 20/80 GERN/JNJ. This all hinges on the internal reviews, slated before the end of this year. So despite the reticence, we will have plenty of developments announced shortly.