Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?
Posted: Tue Oct 09, 2018 6:37 pm
I’m surprised there isn’t more discussion on these items. I know I am not qualified to address it. Hopefully others with the knowledge / experience will help out here. I guess I’m surprised if this is the norm in this day and age of technology and communication. If it all is appropriate, read no further just explain in a response. Thank you.
If it is too long, here are some of my questions / thoughts on the transfer back.
What is the data for? Certainly for MF, MDS, and pre-clinicals but what else and what data is not currently in transferrable form today? Do the CT sites maintain some of the data that must now funnel back through Janssen? Is the FDA somehow in the middle of this? Are the data in paper form?
Are there regulations controlling any of this give-back process?
Can they get the MDS data back first if this process needs to take a year? Can the retrieval be prioritized according to CT so we can get on with the MDS P3?
Is Geron ready to take any of the data? If not, why not and when can they be ready? Is Geron’s preparedness a major reason for this taking a year?
Is Janssen still in the middle of some pre-clinicals and are they allowed to finish before returning the results / data? Also, assuming pre-clinicals or other non-clinical trial activities are in progress, could this somehow be reason for delay? Once the agreement was terminated as of 9/28/18, should we assume that new agreements were not needed to allow for continuation of the pre-clinicals or were they simply terminated and Geron will only see incomplete results for anything in progress at the termination? Or might Geron consider subcontracting with Janssen to complete any in-progress pre-clinicals. If terminated, the data should be forth coming in weeks not months or a year.
I don’t know what will be transferred back besides data. Probably lots of paper documents associated with sites, patients, FDA, Geron, etc. Will there be lab materials? Probably but someone with knowledge would need to answer.
While I don’t know what the data management project plans might look like for the transition, some business experience tells me the following (over simplified) represents part of it:
1. The asset swings back on paper fairly quickly. In this case, the license agreement was terminated on 9/28/18 so on paper Geron owns and controls Imetelstat and all patents 100% as of 9/28/18 associated with CLA. This step is likely done following some paperwork. All ancillary contracts regarding sites doing the CTs, subcontractors, etc. will take longer (weeks).
2. Seems to me that the existing data should swing in a couple months assuming Geron’s information systems can accommodate it and Janssen has maintained reasonable separation of files, docs, etc. Assuming Geron has a data processing environment capable of bringing the data in, accessing / protecting /backing it up this is a relatively finite process. Janssen / Geron will need to test and verify this can be done before actually doing it (weeks).
3. The incremental data is a moving target as new data is being created, retrieved and stored somewhere every day. So for the next period of time until Geron’s CRO takes over the CT reins, Janssen will continue to gather / store the CT data providing updated files to Geron on some agreed on schedule, hopefully at least on a monthly schedule. Seems a maximum of 3-4 months for this all to be cut over to Geron / CRO.\
4. I am wondering what Janssen is allowed to keep in their files post CLA, hopefully they must all be destroyed, including backups. Geron would need some verification on this. So clean up and verification will take some time (weeks).
5. What am I missing? There must be a lot more to this and it can’t all be between the lines?
Now what are the reasons for the MDS P3 not starting for 9 months? Is this standard process otherwise the fact that all the sites, patients, etc. being in place might not mean what we thought in terms of going from P2 right into P3. What does FTD really buy us here?
So maybe the P2 isn’t complete yet and won’t be until 2019 allowing the data to mature. This all may make sense but what is the timeline? And what about MF frontline and AML or any of the other possibilities, how many years away are those trials? And of course the combinations are still in the way-back.
I have become impatient like many of us. I think more advocacy by SA and ImetelChat and even some on Twitter and YMB might be in order as collectively we own a huge chunk of the company. Where are Raza and Tefferi, and what are the Geron plans to ramp up this strategy regarding a new lease on life after JNJ/Janssen. I have grown weary of the bashers coming with incomplete, biased and false information continually pushing patients hopes around endlessly regarding this outstanding science. It seems to be time for us to step up our game as just understanding and sharing the science isn’t getting us where we need to be and hasn’t for a long time!
I know ASH and post-ASH are coming as well as quarterly CCs, but might it be time for the key advocates on these boards to get the oar in the water on playing a larger role?
If it is too long, here are some of my questions / thoughts on the transfer back.
What is the data for? Certainly for MF, MDS, and pre-clinicals but what else and what data is not currently in transferrable form today? Do the CT sites maintain some of the data that must now funnel back through Janssen? Is the FDA somehow in the middle of this? Are the data in paper form?
Are there regulations controlling any of this give-back process?
Can they get the MDS data back first if this process needs to take a year? Can the retrieval be prioritized according to CT so we can get on with the MDS P3?
Is Geron ready to take any of the data? If not, why not and when can they be ready? Is Geron’s preparedness a major reason for this taking a year?
Is Janssen still in the middle of some pre-clinicals and are they allowed to finish before returning the results / data? Also, assuming pre-clinicals or other non-clinical trial activities are in progress, could this somehow be reason for delay? Once the agreement was terminated as of 9/28/18, should we assume that new agreements were not needed to allow for continuation of the pre-clinicals or were they simply terminated and Geron will only see incomplete results for anything in progress at the termination? Or might Geron consider subcontracting with Janssen to complete any in-progress pre-clinicals. If terminated, the data should be forth coming in weeks not months or a year.
I don’t know what will be transferred back besides data. Probably lots of paper documents associated with sites, patients, FDA, Geron, etc. Will there be lab materials? Probably but someone with knowledge would need to answer.
While I don’t know what the data management project plans might look like for the transition, some business experience tells me the following (over simplified) represents part of it:
1. The asset swings back on paper fairly quickly. In this case, the license agreement was terminated on 9/28/18 so on paper Geron owns and controls Imetelstat and all patents 100% as of 9/28/18 associated with CLA. This step is likely done following some paperwork. All ancillary contracts regarding sites doing the CTs, subcontractors, etc. will take longer (weeks).
2. Seems to me that the existing data should swing in a couple months assuming Geron’s information systems can accommodate it and Janssen has maintained reasonable separation of files, docs, etc. Assuming Geron has a data processing environment capable of bringing the data in, accessing / protecting /backing it up this is a relatively finite process. Janssen / Geron will need to test and verify this can be done before actually doing it (weeks).
3. The incremental data is a moving target as new data is being created, retrieved and stored somewhere every day. So for the next period of time until Geron’s CRO takes over the CT reins, Janssen will continue to gather / store the CT data providing updated files to Geron on some agreed on schedule, hopefully at least on a monthly schedule. Seems a maximum of 3-4 months for this all to be cut over to Geron / CRO.\
4. I am wondering what Janssen is allowed to keep in their files post CLA, hopefully they must all be destroyed, including backups. Geron would need some verification on this. So clean up and verification will take some time (weeks).
5. What am I missing? There must be a lot more to this and it can’t all be between the lines?
Now what are the reasons for the MDS P3 not starting for 9 months? Is this standard process otherwise the fact that all the sites, patients, etc. being in place might not mean what we thought in terms of going from P2 right into P3. What does FTD really buy us here?
So maybe the P2 isn’t complete yet and won’t be until 2019 allowing the data to mature. This all may make sense but what is the timeline? And what about MF frontline and AML or any of the other possibilities, how many years away are those trials? And of course the combinations are still in the way-back.
I have become impatient like many of us. I think more advocacy by SA and ImetelChat and even some on Twitter and YMB might be in order as collectively we own a huge chunk of the company. Where are Raza and Tefferi, and what are the Geron plans to ramp up this strategy regarding a new lease on life after JNJ/Janssen. I have grown weary of the bashers coming with incomplete, biased and false information continually pushing patients hopes around endlessly regarding this outstanding science. It seems to be time for us to step up our game as just understanding and sharing the science isn’t getting us where we need to be and hasn’t for a long time!
I know ASH and post-ASH are coming as well as quarterly CCs, but might it be time for the key advocates on these boards to get the oar in the water on playing a larger role?