Recent update to Mayo Study
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- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Recent update to Mayo Study
Fellow board members, please check out my comments on SA and let me know if you read anything into the CT site update on the Dr. T study. bp
Re: Recent update to Mayo Study
BP,
I couldn't find your post on Seeking Alpha's website, so my reaction to the June 16, 2017 Mayo Clinic Study ClinicalTrials.gov website update doesn't reflect your insight(s).
The Mayo Clinic study indicates that it is now scheduled to complete on January 16, 2019. The following outline within the quotation marks is copied and pasted from that update:
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"OUTLINE: Patients receive imetelstat sodium intravenously (IV) over 2 hours on day 1. Patients may continue to receive imetelstat study treatment for as long as they derive clinical benefit or until study end. The study will end when all patients have discontinued study drug, the last patient enrolled has been treated for 5 years, or imetelstat is commercially available in the United States, whichever occurs first."
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The 2nd and 3rd sentences are to me somewhat ambiguous. The study continuation would seem to indicate that patients are continuing to derive OS benefit from Imetelstat, and thus the study end is extended to allow their continued dosing. This is very good news, and it confirms Irish's information regarding her husband's continued benefit. I hope that the January 16, 2019 study end is meant to coincide with commercial availability of the drug.
I couldn't find your post on Seeking Alpha's website, so my reaction to the June 16, 2017 Mayo Clinic Study ClinicalTrials.gov website update doesn't reflect your insight(s).
The Mayo Clinic study indicates that it is now scheduled to complete on January 16, 2019. The following outline within the quotation marks is copied and pasted from that update:
----------------------------------------------------
"OUTLINE: Patients receive imetelstat sodium intravenously (IV) over 2 hours on day 1. Patients may continue to receive imetelstat study treatment for as long as they derive clinical benefit or until study end. The study will end when all patients have discontinued study drug, the last patient enrolled has been treated for 5 years, or imetelstat is commercially available in the United States, whichever occurs first."
---------------------------------------------------
The 2nd and 3rd sentences are to me somewhat ambiguous. The study continuation would seem to indicate that patients are continuing to derive OS benefit from Imetelstat, and thus the study end is extended to allow their continued dosing. This is very good news, and it confirms Irish's information regarding her husband's continued benefit. I hope that the January 16, 2019 study end is meant to coincide with commercial availability of the drug.
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Fishermangents
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Re: Recent update to Mayo Study
Bio, thanks for kicking this off here. I agree with your observations. The Mayo Pilot hasn't been designed for getting approval, unlike IMbark and IMerge. My take is that extending the study-end therefor is not directly related with the approval process and has more to do with studying long term effects (maybe other hem-indications) and probably also with patients still receiving benefits.