Replies to post #179953 on Biotech Values

[jq1234]

Now it seems clear why AGN bought Levadex manufacturer after MAPP acquisition. From CRL last year:

Per the FDA's comments in the CRL, during a previous inspection, the agency noted concerns with Exemplar Pharma, LLC, the canister filling unit manufacturer. In accordance with Allergan's overall manufacturing strategy to secure our supply chain, Allergan completed the acquisition of Exemplar on April 12th, 2013, for less than $20 million. Allergan has appointed senior members of Allergan's Global Technical Operations to oversee the facility. Allergan anticipates that the FDA will require a re-inspection of the Exemplar facility prior to approval.

The FDA also noted concerns regarding the manufacturing process for the final filled canisters. Allergan has already responded to this concern. As the FDA indicated in the CRL, the Agency has not yet reviewed Allergan's response under the current PDUFA timeline.

http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=756760

Per BioWorld today, AGN re-engineered the manufacture process to make it more robust after they bought the manufacture plant.