“Let's not under-estimate the rest-of-world market and that some ROW approvals may (likely) come ahead of the FDA. “
Yes, I hope so. Missling has been bypassing the FDA for the most part. I don’t see why he wouldn’t apply elsewhere. Unless he was advised against it. Unless it would leave a bad taste in the mouth of the fda.
Missling knows the fda is the gold standard and I’m sure is aiming for their nod. If the relationship is productive, he may not go for an overseas approval, etc. Even though we all want him to. It actually may force their hand. I’m sure it has been discussed in their boardrooms.
If the TGA hints at some accelerated path especially for PDD, I’m sure he would jump at the opportunity. This news drought is indeed frustrating, however, I believe news is in the horizon.
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