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Posted On: 01/08/2020 12:03:52 PM
Post# of 149265
Re: SouthernGold #14549
Yes , it is , because of rolling review , and first part submitted in March 2019 , and FTD , we should be approved imo no later than July...
But I think because of above reasons , we have a chance to be approve within 3-4 months after submitting BLA , since we are in this unusual situation that FDA needed to review our clinical results before recommending the dose of 700 mg to be use in combo.
All is good now ...
All IMO .
But I think because of above reasons , we have a chance to be approve within 3-4 months after submitting BLA , since we are in this unusual situation that FDA needed to review our clinical results before recommending the dose of 700 mg to be use in combo.
All is good now ...
All IMO .
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