Why a trial?, page-26

Simple rule of thumb is the more innocuous the contents of a CRL the happier companies will be to share the details.

Here we have two words – “more data”.

So the working assumption is that the FDA were completely unconvinced by the resubmission and have not budged one inch from their “at least one additional randomised controlled trial” position.

There is a slight possibility this might not be true.

In the first CRL MSB went straight to appeal; this had the effect of finalising the CRL.

In CRL2 MSB are heading to a Type A meeting. And so they can argue the process is still in progress; a incomplete negotiation. So with backwards and forwards still to come what is in the CRL today may not be there tomorrow.

Bear in mind that a CRL itself is a summary. A few pages summarising what will be hundreds / thousands lines of emails / discussions etc within the FDA. And so MSB might not have a good understanding around the FDA thinking behind some issues or how strongly their positions are held.

But realistically I don’t think anything now can change the path that gvhd is on. Which is heading to Gods waiting room. An academic network will be tasked with doing some design work and identifying opportunities for funding. In a couple of years only the old timers here will remember anything about it.

For now there is far more pressing issue of funding. If people recall a week or so ago I did a simple back of envelope risk reward calculation to get a handle on the market odds for probability of approval. I used an estimated downside share price of 80c in the case of rejection. Given a share price of around 110c my prognostication was the rejection would be a anti climax because the market was already pricing in failure.

This will make the top 5 of my silliest HC predictions.

I was completely oblivious to the financial consequences from the CRL. This was because finance is not my area of interest, I have no skills in it and consequently I never bother about it. Big mistake because the here the two – the clinical and finance were interlinked.

So that is one big lesson I have learned. Don’t forget that a biotech with complex opaque financial arrangements is a house of cards that may not be very resilient to a few puffs of wind from the FDA.

But from this perhaps flows the only glimmer of positivity I can see for MSB. We can debate SI’s skillset but no-one doubts his fund raising abilities. So SI might be the man for moment to put out this dumpster fire in a train wreck; which admittedly is of his own making.