There was a rolling BLA that ran for months and months. The responsibility to iron out all of these issues was then - that responsibility is on MSB as they are applying for FDA approval with the FDA!!
Via the minutes of the ODAC meeting the FDA asked questions relating to their published guide in this area that MSB has just spent US$9.5M in addressing.
Those that were directly impacted by the FDA not issuing an approval for AGVHD did not rage against the decision. Not one of them. Also no negative media regarding the decision at all (outside of inferred statements made by SI).
You are saying the goal posts were moved by the FDA because you got that from SI. It doesn’t ring true given what has happened since. The FDA has not issued any new requirements.
The US$9.5M is an admittance of responsibility. Always follow the money. Money talks. Everything else is guess work.
Cell Therapy News/Articles, page-11106
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Last
$1.06 |
Change
0.030(2.91%) |
Mkt cap ! $1.221B | |||
| Open | High | Low | Value | Volume |
| $1.05 | $1.09 | $1.03 | $5.418M | 5.074M |
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|---|---|---|
| 17 | 63773 | $1.06 |
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| Price($) | Vol. | No. |
|---|---|---|
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| MSB (ASX) Chart |