Impurity and localised reaction are quickly, easily and...

Impurity and localised reaction are quickly, easily and inexpensively fixed. Paul Rennie pointed out that localised reaction is a normal feature of subcutaneous injection, and oxidation impurity is a normal occurrence in manufacturing peptides.

Efficacy is going to have to wait for the MS study to complete, which is going to take until February '23. That is unless something causes the results to be delayed...

The Alzheimer's study from University of Tasmania quite prominently highlights that there is a difference in efficacy between the dimeric and dendrimer forms of the peptide. The author uses the term "tetrameric" rather than "dendrimeric". The study is here:
https://eprints.utas.edu.au/23104/
And the information is in the second paragraph of the abstract, where you find it after about 30 seconds of reading (providing you skipped the acknowledgements, planning to go back and read them later, which you should do, because thesis acknowledgements are often rather funny, or at least fun):


So... if the first two are "normal", and the efficacy difference is pretty clearly communicated in the original research, the company needs to address some issues going forward.

1. There needs to be somebody in the driving seat who has the experience to anticipate what kinds of issues regulators, boards and committees are going to care about.
2. Because nobody can think of everything, there needs to be at least one of those irritating people whose job it is to ask insanely annoying "what-about" questions to make everybody second-guess themselves before they launch into action.

That second person is incredibly hard to find.