Search found 24 matches
- Tue Dec 04, 2018 5:33 pm
- Forum: ImetelChat
- Topic: compassionate use program?
- Replies: 9
- Views: 4431
Re: compassionate use program?
I got this back this afternoon. Thank you for your interest in Geron, your feedback is appreciated. Compassionate Use, or what is now referred to as 'Right to Try' is not something that Geron is considering at this time. Once the IND transfers back to Geron, which is expected to coincide with the ti...
- Wed Nov 14, 2018 11:12 am
- Forum: ImetelChat
- Topic: compassionate use program?
- Replies: 9
- Views: 4431
compassionate use program?
When JnJ added imet to their compassionate use program, was this acknowledged as a mistake? Or was it added because it was needed and then removed due to the business decision. If we assume that it was a business decision that forced it being taken down, should geron be providing access to this unde...
- Tue Oct 16, 2018 10:39 am
- Forum: ImetelChat
- Topic: FDA Thoughts on Accelerated Approval
- Replies: 6
- Views: 6221
Re: FDA Thoughts on Accelerated Approval
For accelerated approval I thought part of the process was to inspect the manufacturing facilities of the company.
Geron still needs to resolve that question. Out sourcing it to already existing facilities or building there own.
Either means that the approval isn't just around the corner.
Geron still needs to resolve that question. Out sourcing it to already existing facilities or building there own.
Either means that the approval isn't just around the corner.
- Wed Oct 10, 2018 9:50 am
- Forum: ImetelChat
- Topic: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?
- Replies: 11
- Views: 4605
Re: Why does Janssen need 12 months to transition the data to Geron & 9 months to start a P3 in MDS?
Gentlemen, Its not data that will take time. Its the on going treatment of the current patients, plans, costing, meetings, back covering, more meetings. Waiting for results from other sites, correlating them and then more meetings. We could read in to any delay all our nightmares, but these things d...