When the fracking hell will receipt of the SPA be announced? This question is one of at least two questions on my mind in the very near-term. The other: When will the top-line psoriasis Phase 2c trial results be released?
According to Mark Monane, MD, Vice President and senior analyst in biotechnology and biopharmaceuticals, Needham & Co, New York, “Having an SPA in place is especially important if it’s the company’s first drug in late-stage development.” Other situations where an SPA is a desirable possession are when the drug entity in question is first-in-class, or has (or could have) orphan status designation. This is particularly true in oncology where drug development frequently explores uncharted terrain. “The SPA is very helpful because it lays the groundwork. It gives you a trail to follow,” he said. Not that you still can’t get lost, he commented, saying, “Yes, the agreed upon protocol exists as a sort of contract with its itemized expectations, and you have to live and breath by this thing. But, as the trial develops and you want to make changes, those are harder to make because of the SPA.” According to Monane, there are fewer degrees of freedom with SPAs than if a company had proceeded on its own. To be clear, an analyst is not privy to the SPA’s provisions, but it creates a comfort zone. “It’s like a recipe for a cake. It takes time, attention, and love to get the cake right.” However, the recipe isn’t enough, there still needs to be an effective team in place to do the work. “I definitely use the SPA as one of my check boxes,” he says, “You still have to execute, but it’s a nice place to start.” Source here.