Median OS in IMbark

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Fishermangents
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Median OS in IMbark

Post by Fishermangents » Mon Jan 15, 2018 4:27 pm

On SA there has been an interesting contribution from MedTechBio (MTB), who elaborated a theory on the estimated median OS in IMbark, based on the information we have today. Here are some quotes.

Median survival for patients taking Imetelstat may already exceed double and may soon exceed triple the expected timeline for patients admitted into the iMbark trial.

IMbark MF P2 Trial Key Dates:
Sep.16, 2015 - First patient dosed in IMbark
Sep.16, 2016 - Geron announces results of internal 12 wk review of first 40 patients in the trial
April 10, 2017 - Geron announces completion of 24 wk review of all 100 patients in the trial
Q1 2018 - Internal data review to enable a potential protocol amendment to allow the long-term treatment and follow up of patients beyond April 2018 end of study date

'Using the key dates above as well as other publicly disclosed information from SEC filings and investor presentations, I developed an enrollment timeline under a worst-case, best-case and most-likely case scenario on a quarterly basis.'

'Should median overall survival not be reached by the end of January, the best-case scenario suggests median survival can be as high as 22.2 months and a worst case scenario of 18.1 months, each clearly sufficient to garner FDA favor for expedited approval. My estimate for a most likely scenario is that should median survival be reached at the end of the month, the measure should read very close to 21 months. No street sell-side analyst, to my knowledge, has done the calculations, at least not publicly.'

Link to the full article: https://seekingalpha.com/article/413722 ... a-approval

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