Hi @whenwill thanks for the tag.
In short, I don’t know. Like many, I expectedthat there would be challenging questions / statements, but for the FDA tostate the data doesn’t demonstrate a clinical relationship was a shock. How doesMSB overcome that, not easily i'd suggest. Reading some other FDA ODAC briefing documents, they are much more extensive and frankly less critical, which is worrying.
If you read the FDA briefing doc, they statethat they “do not believe the data currently demonstrates a relationship withclinical outcomes.”. They ask ODAC to discuss other characteristics not previously identified that might be meaningful measures of product quality and potency. The FDA has stated the data has been confounded…. These are not insignificant statements to be brushed aside as some suggest, but nor are they necessarily terminal. Other posters rightly point out there are no safety issues, no alternative treatments & there are precedents for single arm trials. Reading the statements and trial results i personally believe there is efficacy, but i'm not the one to convince unfortunately.
I’m going to re-read the MSB submissiontonight, it will take some digesting.. Given the price drop and significantnews to come, I may buy back tomorrow or wait to see the ODAC results. There are numerous milestones coming up for investors to re-assess their investment in MSB, sell or buy.
GLTAH
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Hi @whenwill thanks for the tag. In short, I don’t know. Like...
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