Description

There's a primer on DBVT from another individual that's fine.

Here's what happened: DBVT is a French biotech company that has a treatment for peanut allergy for children agees 4-11.  Of note, this treatment is a patch that parents put on their kids daily and it exposes the kids to microgram amounts of the peanut allergen, which desensitizes (reduces peanut allergic reaction) the peanut-allergic kid.  So, instead of anaphylaxis and not breathing when you accidentally eat peanut when you're on a trip and eat at a restaurant, you now just have hives and don't feel well.  Instead of having hives and not feeling well, you have a small itchiness or nothing at all.  Basically, it reduces the allergic reaction and provides peace of mind for everyone.

Sounds great, right?

Before I get into making fun of the French, please note that this is in complete jest.  The French management team is, well, French.  Of note, Susanna Mesa is a fast talker who just keeps talking and doesn't know half the stuff she talks about.  But she'll keep talking.  Susanna also never told anyone or disclosed the lower bound of the confidence interval is 15%.  This is a firable offense and the fact that she wasn't fired, but rather promoted, shows you how French this French company is.  Susanna is not French but she is more French than most French people.  Outside of Susanna, the CEO was quite French and just smiled and nodded and didn't know whether the sky was up or down.  That CEO's gone.  So, that's a positive.  Outside of Susanna, the management team is moving in the right direction.

But none of that really matters.  What matters is what happens with the FDA, which I think will be that the FDA accepts the application, which DBVT filed in late October.

This is a binary event because bears believe FDA won't accept the filing because DBVT missed their primary endpoint.

I think it is likely the FDA accepts the filing because i) technically, DBVT missed primary endpoint but the whole body of evidence suggests the treatment works ii) unmet need: nothing out there for this and this peanut allergy thing is a big deal iii) incredibly safe: you can remove the patch if it itches and that's about the only side effect you get iv) FDA is not as dumb as most people thing and stick only to hard and fast rules--they think about what's out there and make judgement calls on that.

Also, the event will occur before year end.  No fund wants to have somethnig that could be down 99% happen right before the year ends, esp if the year has not been great.  But if you have the ability to think longer term and are willing to think about what's most reasonable (not saying I'm going to be right but more likely right than wrong), then you'd be there for this 'acceptance' of the filing, which is not really that big of a hurdle.  Just to be clear, it's acceptance of the filing for review by the FDA, not thte FDA saying they'll approve the product.

So, whaddya say, is it worth the risk?

I think so.  Upside 4x vs downside 1x.  4:1.  I'll take that outcome everyday and hopefully, I'm right more than I'm wrong.

Catalyst

FDA acceptance of BLA filing