Welcome back ab. Your contribution is always valuable.
The part of the Dec 27 announcement I find most telling is this statement:
“Encouragingly, the FDA did not identify any approvability issues in relation to the safety, manufacturing or quality of VivaGel® BV.”
While on the surface this is reassuring, it also suggests the FDA have identified specifically which parts of their submission they deem to be insufficient.
I can understand why SPL would not want to reveal that, or why they may feel they can address these issues. Whether that is information SPL is obliged to announce to the market or not remains to be seen. In my opinion it is. Maybe the shutdown has clouded the issue, or maybe SPL are using it to buy some time themselves, perhaps hoping that it’s not as bad as it appears.
SPL Price at posting:
$1.13 Sentiment: Hold Disclosure: Held
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