The Life Sciences Report Interview with Chen Lin (2/20/14) "AcelRx Pharmaceuticals Inc. produces a product to replace morphine after operations. . .a revolutionary painkiller, Zalviso (sufentanil sublingual microtablet system), which can be put under your tongue. Patients can self-control the amount released to reduce pain. The drug is set for approval in July of this year. . .the painkiller is a controlled substance. It is released in increments by a secure, self-controlled device. It is only for use after an operation and only by prescription. AcelRx has a related product, ARX-04 (sufentanil acute pain nanotab), that is in development for the Army to use on the battlefield. That is further back in the pipeline—in phase 2—but it looks to be a very positive product. . .I hold a strong position in AcelRx. . .it is still a very good buy, with lots of upside, because the FDA approval is probably worth $30–40/share
- I don’t know that many people realizes that ACRX Zalviso actually solves one of the main concerns of FDA acceptance, that is substance abuse. If I was the FDA I would actually pay ACRX for this solution, why does the FDA even need to approve this. This puts this in a completely different league from other drugs out there going under evaluation. This is a game changer for medical science.
- Chen Lin also said: We all have been with or seen people who recently have had surgery. Patients usually have needles stuck in their arms to inject morphine. It takes usually two nurses to double check and make sure that the right amount of morphine is being injected with a standard IV. But still, one in every nine IVs has an error. That has created a lot of potential liability for hospitals and is also bad for the patients. In addition, as a patient, placing an IV is a very uncomfortable process, and it can be hard to move around with an IV.
- Therefore this benefits the FDA, this benefits the hospitals and benefits medical practitioners, and it is a huge benefit to patients. Which patient would not want this instead of an IV? Incredible, this is the next era in the making.
This was from the interview with expert Chen Lin - He estimates that FDA approval is probably worth $30–40/share. This is a powerful - it means that we should see a run-up to at least $20 or more before FDA approval in 4 months.