Jeff, as I understand it the FDA won't even look at the clinical data in an NDA unless it is Certified by the NIH.
By looking at the definition, and as Silvr mentioned, it certainly looks ANIP, or a partner such as AbbVie, are preparing to file an NDA and use the data to support their filing.
The question is Libigel the drug that will be filed or is the data being used to support a drug like Intrinsa with a smaller patch.
The safety trial was also collecting HSDD efficacy and we do not know all the secondary outcomes from this trial. Based in the data treating Hypertension? CV event reduction and Breast Cancer event reduction could all be on the table for future studies if the drug gets approved.
From the clincal trial website.
Certification Requet
A sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can delay results submission up to 2 years after the certification/extension first submitted date, unless certain events occur sooner.
An extension request likely does not apply as the primary completion date is October 2012. Even if AbbVie and Snabes continued following the participants to the end of what was suppose to be the post marketing portion of the trial, the primary completion date would be June 2016.
Extension Request
In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed. See Delay Results Type in the Results Data Element definitions for more information.
ANIP could of decided to go it alone, but that is unlikely. A global partner such as AbbVie would still be needed.
If it is AbbVie, AbbVie is already predicting a revenue erosion in 2023 as biosimilars for Humira come on line. Everyone except Alvotech settled and the launch dates are staggered. They also negotiated royalties to be paid to AbbVie. If Alvotech wins they a launch immediately in October 2022 and they will be the first to market a good 3 month a head of Amgen and they won't be burdened with any royalty payments. AbbVie's stock will take a huge hit. If they intend to use Libigel to counter a greater and faster Humira sales loss, They will want it approved by September or October 2022. If they use a Priority Voucher they could file an NDA in March or April 2022 and still get it approved by October 2022.
If on the other hand ANIP is advancing Libigel on its own. Look for a Corti profits to fund the regulatory filing, so it could take a little longer to file.
AI
