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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: drtom1234 who wrote (45929)4/27/2018 9:09:22 PM
From: weatherproof7 Recommendations

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and 2 more members

  Read Replies (1) | Respond to of 58497
My thought is that they set out accruing a minimal amount of patients for the first stage in a 2-stage phase II. It is my sense that the response rate in both urothelial and hormone positive BC were high enough to reject the null hypothesis (drug inactive due to lower than a predetermined response rate.) I'm also doubtful that the trial was stopped for efficacy. I think we're just seeing the trial suspended as they take the numbers from the basket trial representing stage one, and now determining the sample size, and such, for the second stage. The bad news would have been that they're not proceeding with the second stage due to inactivity of the drug or some issue with toxicity. I don't believe we're seeing any signs of that.

To: drtom1234 who wrote (45929)4/28/2018 11:49:18 AM
From: plhky34652 Recommendations

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Is it possible that any of this is related to the content of Fitz's post 44636 which i copy below??

FDA to Allow Quicker Approval of Some Promising Cancer Drugs
Commissioner Scott Gottlieb says there will be more cases of drugs that show early and large potential.

By Thomas M. Burton, Wall Street Journal

The Food and Drug Administration plans to allow quick approval of some cancer drugs if they show early and “outsized” survival benefits for patients even in small studies, the FDA’s commissioner said Thursday.

Scott Gottlieb told the House Energy and Commerce subcommittee on health that the agency expects to see this situation more, given the advent of drugs that precisely target the genetic underpinnings of diseases.

“We’re going to see more such cases,” he told the committee members, “where a new drug offers an outsized survival benefit in a selected population of patients in a smaller, early-stage clinical trial.” Such cases, he said, “are compelling us to explore new ways to facilitate and expedite the development and review of these products.”

His concept is essentially an expansion of what the FDA currently does in what the agency calls accelerated approval. It now can approve a drug based on early evidence but require that the manufacturer do a confirmatory study to keep the medicine on the market.

Currently, such approvals are based on endpoints like tumor shrinkage that are believed to be “surrogates” for clinical benefits, such as survival. Dr. Gottlieb’s new proposal would be based directly on overall survival “in a rare or deadly cancer,” he testified. The concept could be used for drugs that don’t have FDA approval or to expand the approval already in existence.