Updated Broker Report: Bel Potter, page-120

There seems to be a growing concensus on here that the FDA never planned to give full approval. And that the CRL is just the FDA pushing MSB to apply for the Accelerated Pathway, therefore covering themselves with a further trial and sending a statement to all companies applying for medical treatments - no shortcuts. ( if I can summarize simplistically)

But it doesn't explain to me, why when having all of the advantages of Fast Track Designation & Rolling Review, MSB were still seemingly ambushed by the decision.

Fast Track designation -
1. More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

2. More frequent written correspondence from FDA about such things as the design of the proposed clinical trials

Rolling Review -
Company can submit completed sections of its application for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.


With all these advantages, how was it that MSB was not made aware earlier that they were going down the wrong path for approval?

I was under the impression the process was almost akin to the marking lecturer reviewing & advising on a thesis throughout the writing process.
But after submitting, being told the thesis question was invalid from the start.

There is still so much unexplained. I fear any expectations that MSB will have the decision overturned by offering a post approval trial is positive thinking. Surely if it was so simple MSB would have been made aware of this a long time ago.
It's very confusing, I'm in the dark.