Ann: Half Year Report and Accounts (including Appendix 4D), page-214

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bridog

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28/02/21

01:46

Post #: 51393567
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Originally posted by col69: ↑

This backs up my earlier comments - FDA has made it clear that they require additional trials in all applications

Really ? Aren’t you just making assumptions that this is the case .... hard to make that determination from that one sentence without knowing the facts or seeing minutes of the FDA meetings ....

1. Has the FDA had time during COVID to have meetings on all MSB phase 3 indications - I mean the initial CLBP results were only released very recently so I doubt they have even met about this indication at all ?

2. The reference to “Confirmatory Trial” may be focused around an Accelerated Approval for Ryoncil and the agreed adult trial after the approval - confirmatory trial ? No one knows where this process is at yet so it cannot be ruled out ? If this were the case it would still fit with “as per FDA requirements” as detailed below would it not ?

https://www.fda.gov/drugs/information-health-care-professionals-drugs/accelerated-approval-program

Accelerated Approval Program

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market

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Well put @col69, I think this bloke is becoming a serial downramper. Makes statements that at first glance appear reasonable, but when you delve a bit more are not correct.

MSB Price at posting: $2.46 Sentiment: Buy Disclosure: Held
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Ann: Half Year Report and Accounts (including Appendix 4D), page-214

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