The CRL would be more detailed than the two words "confirmatory data", but it won't be so prescriptive as to eliminate all ambiguity.
As such, when responding to a CRL there is always an eliminate of guesswork - albeit an educated and informed guess. Hiring ex-FDA consultants is a given when responding to a CRL, each and every pharma company would take this step. It is prudent and expected of Starpharma to do so.
As such, having these consultants don't give me any extra confidence that they will get a favourable outcome with the FDA in this meeting.
Heard of the song "Ironic"? This line springs to mind ... "It's like having 10,000 spoons, when all you need is a knife".
Doesn't matter how many dollars you spend on advice, if the regulatory body wants a knife and you give them 10,000 different types of spoons .. you will still get knocked back.
Something to keep in mind is that the FDA chooses its words very clearly. If they needed more clinical data, they ask for clinical data in their CRL.
If they want another trial, they ask for confirmatory data.
Starpharma are giving them more clinical data (another spoon).
So all I am saying is that Starpharma are going to be fighting an uphill battle at this next FDA meeting. I am not saying they can't win, I am just pointing out that it won't be easy and the odds are currently against them.
Having partial approval for one indication is not ideal, but possible and better than no approved product this year.. but that is pure speculation on our part as we don't know what is in the CRL. It may sound logical, but there are so many possibilities out there ... how do I justify to myself as an investor to place my hard earned cash based on two words "confirmatory data". Especially when I know what that means.
It's risk awareness and capital protection that I am advocating, and my risk appetite is different to everybody else. However I feel an obligation as part of an investor forum and former shareholder to share this view.
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