CRL or Approval???, page-45

Let's get the facts straight.

• The paper that discussed the FDA going against panel recommendations researched the period between 2008 and 2015.
• It found 22% of the time the FDA went against the panel recommendations.
• Of that 22%, 50% were in the first 2 years of study period and only 10% happened in the last 2 years, showing that the FDA has become progressively less inclined to go against the panel decision.
• Of the times the FDA has gone against a panel decision, 25% of the time it decided to APPROVE the drug against the panel's recommendation to reject.

So that would mean, the FDA went against a panel approval only around 15% of the time during 2008-2015, but most of these were in the first 2 years. In the last 2 years the overturn, rejection rate was 3%. As the list of papers were not easily obtainable, it was not possible to judge how many of these 3% were from panel approvals that were close to deadlock as opposed to a clear (say 9-1) decision.
It is false to claim that the likelihood of rejection is anywhere near 20%.

In addition a number of other "factors" have been claimed by posters mainly around efficacy/potency and the ability for MSB to control manufacture quality of Remestemcel-L. This is rather moot, since in the case that the FDA will be ruling, the prognosis of the patient is dire and no alternative treatment is being sacrificed by using Remestemcel-L. The ODAC ctte were convinced of both safety and efficacy, so the only possible downside of intermittent manufacturing quality is a lower success rate rather than increased mortality above the current placebo baseline.

While no-one can be sure of how the FDA will make its ruling, none of the data available publicly points to any outstanding issue that would prevent its approval and nothing that has been pointed out by recent posts provides any reason to believe the outcome won't be for an approval.

[All the above are based on public data and are my opinions based on reading the source material available]