CTtrials site
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- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
CTtrials site
Both Janssen trials updated yesterday. bp
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Fishermangents
- Site Admin
- Posts: 529
- Joined: Thu Dec 03, 2015 3:39 pm
Re: CTtrials site
Very interesting! There are some changes to the protocol of IMerge. They skipped the following sentence completely: "../.. in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment.".
The following sentence has been removed too:
"phase (until disease progression, or unacceptable toxicity, or withdrawal of consent, or lack of response)".
I consider these changes in the protocol as an important sign that they have good reasons for making imetelstat available to the a broader group of MDS patients population. That can only be based on a certain level of success so far and with the consent of the FDA.
The following sentence has been removed too:
"phase (until disease progression, or unacceptable toxicity, or withdrawal of consent, or lack of response)".
I consider these changes in the protocol as an important sign that they have good reasons for making imetelstat available to the a broader group of MDS patients population. That can only be based on a certain level of success so far and with the consent of the FDA.