There is no doubt that there is a faster path to market as you have said and a high unmet need is an essential criteria. From research I did ages ago another important factor was whether the drug seeking a faster approval had a high adverse event risk. It was also clear that the approval could be conditional and restricted to patients at the end of approved treatment pathways who have little time and no other hope.
Across all of the information that has been released by VLA it seems to be achieveing its results in areas of high unmet need and has a very low risk profile for adverse events. Indeed it has actually in completed Phase II results with Keytruda appeared to have reduced the adverse risk profile of Keytruda over when Keytruda is used alone. You would need to check but I think I read that this was not the case for Keytruda when used with other immunotherapies???
Although I could not find it I thought that VLA released results in 2017 of a trial of Cavatak alone which was solely addressing risk of adverse events which showed its risk profile was identical with a placebo. The release was a little technical from memory and was followed by an explanatory release explaining that this was a very good result. In other words at least in that trial taking or giving was no more dangerous than taking or giving a sugar pill.
This sort of approval though is not easily achieved where FDA is concerned and I am in no way an expert in this area but on my research it was at least a possibility in VLA's case.
VLA Price at posting:
82.0¢ Sentiment: Hold Disclosure: Held
