I find Neostem to be a very promotional company -- remember the Vatican stem-cell conference carnival? -- so let's just say be careful when CEO Robin Smith and her crew press release the AMR-001 data.
Speaking of Robin Smith and promotions, I wasn't joking when I predicted she'd restructure Neostem by launching a chain of stem-cell smoothie shops. In fact, Smith has already done it.
A few years ago, Smith partnered with a pyramid marketing company to concoct and sell a "liquid nutritional supplement" designed to "optimize" the health and function of adult stem cells.
This is my favorite YouTube video of Smith hawking her "AIO" stem cell beverage. I particularly like her white lab coat and the stethoscope slung across her neck. The snake oil sales pitch in the video really heats up at about 1:25.
It's hard to take Neostem and AMR-001 seriously while Smith runs the show.
Two emails, related, on MannKind (MNKD) and my prediction calling an FDA rejection of its inhaled, rapid-acting insulin Afrezza.
John T. writes:
Adam, long-time reader. What are the reasons you believe the FDA will reject MannKind's Afrezza? Just curious. Stock certainly sold off hard in August following MannKind's discussion of results. Is there something the company isn't telling us?
Jeff B says:
Adam, I strongly disagree with your negative article on MannKind Alfreeza. I don't think it will be rejected. Why do you and Cramer hate MannKind so much? I used to always respect and even manage my portfolio by what you guys said. But since I've owned MannKind I have been disappointed with both of yours comments. I have a MBA in Economics and respect most of what you say. I just don't see you two continuing to knock MannKind this third time around... I think you and Cramer will regret not being behind this one.
Here's my thinking on MannKind on why I predicted an FDA rejection of Afrezza:
The results from the two phase III studies announced this summer were barely passable. In Type 1 diabetics, Afrezza was numerically worse than Novo Nordisk's (NVO) Novolog. The study met its primary endpoint -- barely -- only because MannKind set a low bar with respect to the statistical non-inferiority endpoint.
Results from the study in Type 2 diabetics were more favorable for Afrezza but still, the product under-performed relative to MannKind's expectations. Afrezza also caused more weight gain in Type 2s.
We still don't know, exactly, how the current "Dreamboat" inhaler performed relative to the older Medtone inhaler. And MannKind has been flinty with Afrezza safety data. We know the inhaled insulin causes a persistent cough. MannKind claims the cough is benign, but what will FDA say?
Investors have not taken well to the Afrezza data. Here's a chart of MannKind plotted against the NBI since August.