Ann: Clinical Trial Supply Agreement with Merck KGaA and Pfizer, page-56

Great analysis there as always!

Over the years, I have been following development of some of the major pharmas dealing with the FDA for drug approval. One theme in common is that FDA tends to give 'provisional' approval to market in drugs targeting highly unmet needs, especially if they can prove up safety first and foremost.

So here we have Her-Vaxx, targeting a highly unmet need. If the preliminary result should show first and foremost that it does not add toxicity to the combo trial (which the whole B cell platform has in spades based on previous trials) and that the combination is at least better than currently available treatment, then chances are Merck will do a deal here with IMU and approach FDA for a fast approval to market while it is still on trial. This has happened on many occasions with continuous audit by the FDA to ensure it is all going well until final approval.

In view of that, this trial now only need to prove safety and that it is better than what is out there. If that is achieved here, Her-Vaxx could go to market earlier than expected. Especially now the big boy is involved here.

Be excited. Be very excited