A call with Matt Beck, Apriluv spoke to Matt Beck, and the 2 of us discussed his call and my recent conversation with Rich Pascoe back in March. Here are our conclusions:
1. Takeda, Sandoz and the rest of the EU are pissed off because of the delay in the Room Temp Device
2. Ferring is excited because taking over the UK will help them expedite approvals in Latin America. Mexico will be first with approval then Brazil.
3. Pascoe has held back the room temp device or is still working with the materials to get it right. Don’t know for sure, Pascoe told me there was not a problem with the room temp device, so did Matt Beck, they could be spinning it though, either way, approval in the USA is much faster with the cold temp device and that gets DDAIP approved in the USA, therefore a good strategy, they can get Vitaros moving in the USA and can out license DDAIP once it’s approved in the USA. Seems strange that they would diminish the EU situation by holding back RTD there, do they not have the cash, or more likely they are still working out the materials and stability studies and just putting the best spin on it they can. Sounds more like spin to me.
4. Once Vitraos cold temp is approved in the USA, they can also add another DDAIP product to the pipeline knowing the safety and manufacturing hurdles for DDAIP are overcome with the FDA.
5. The current cold temp device is being improved to last 7 days out of fridge, but in the EU they will only allow 3 days stated on the label, I’m assuming in the USA and Latin America the 7 day will be on the label.
6. Pascoe told me 2 things, one, they have Vitaros as a foundation of the company , and two if Fis. failed in E.D. they would go for the Luts indication later.
7. Femprox is dead, Fis. for LUTS by APRI in the USA will come back once they have cash again, Rich and Matt both indicated this.
8. Rayva out licensing in the EU will provide the cash to move ahead with USA PH2B trial.
9. They are talking to Mylan again, we’ll see. Canada not as important as Mexico or Brazil at this point.
10. They have confidence in USA approval, but we all know how that goes, any delay will be devastating.
It’s been so many disappointments with Apri, there’s still hope though, alot could happen in the next 12 months, let’s hope it’s not more of the same disappointment. |
