Since you asked I'll offer an opinion—an uninformed opinion.
As I read the letter, everything in it has a known solution that only involves spending money. It's not as if they have to develop and validate a new assay. When the FDA says "you should do something" and Immunomedics says "yes, we will do that—right away, sir," I don't think it would affect the PDUFA date, though approval might be conditioned on Immunomedics actually doing what they said they would do.
The larger problem is that Immunomedics has stocks of antibody made in a facility with deficiencies—how serious FDA takes these deficiencies to be I can't tell. For example, let's parse this:
"The investigation revealed that the firm's quality control unit didn't have the authority to investigate critical deviations that occurred at the facility—namely a February 2018 data integrity breach, which didn't trigger a deviation. This breach included manipulated bioburden samples, misrepresentation of an integrity test procedure in the batch record, and backdating of batch records, such as dates of analytical results."
The actual complaint here is the lack of authority within the company for the "quality control unit" to investigate a problem. However, the problem itself would seem to be sufficient to require the company to reject the affected batch(es) of product.
"The firm also had issues with differential pressure in GMP areas of different classifications. Specifically, it didn't properly maintain air pressure; the pressure between a Class C room and Class D corridor was out of action levels in 37 measurements between July 24 and August 1, 2018, the agency said. Additionally, not all adjacent rooms with different air classification had alarms for low pressure differentials."
What this is saying is that the company didn't have safeguards in place to prevent product contamination due to stuff in the air. It's not evidence that any contamination occurred, but the facility didn't meet GMP (Good Manufacturing Practice) standards.
All of these things together indicate that the company may have to remanufacture antibody—after all the necessary fixes are made, and before they are allowed to market it. If so, we may not be able to ramp up sales as quickly as anticipated. Or, FDA may be of an opinion that the risks of faulty manufacturing are outweighed by the risks to the public by withholding the drug (as it is) from the market. There's no way to tell just based on this. |
