We will be leveraging Aptars experts to fast track FDA approval. From the article;
”Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to help accelerate approval”
The drug Spontan delivers is already FDA approved…the delivery mechanism is not, but Aptar whose system we will be using have already been before FDA with neffy for their nasal system. FDA approval could happen a lot quicker than anticipated.
Ann: LTP Secures Global CoDevelopment Agreement with Aptar Pharma, page-69
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