Javelin Pharmaceuticals Inc (JAV)

[Paullee]

"Any thoughts on future FDA caution on safety hold-ups for intranasal PM-150 or intranasal rylomine given that the FDA has placed YMI's intranasal opioid based pain-killer AeroLEF on clinical hold for safety concerns? How do JAV'S intranasal products stack up to YMI? Since 1/17 and prior to the shelf PR, JAV has been trading down. I am long JAV and any thoughts are appreciated. "



First of all, the FDA had originally allowed the company to file for military and emergency use based on 4 PK studies which showed that had they had any reservations at the time, they would have likely required full blown clinical trials. subsequently, the FDA wanted a small safety study to explore multiple dosing. This is more of an annoyance requirement as the military gives the drug in IV formulation at 50 times the dose of PM-150.

As well, one of the main benefits of Ketamine vs Fentanyl (which is an opiod --ketamine is not) is that it does not depress respiratory responses which if i understand this correctly is what YM is experiencing. In fact, one of the main benefits of using PM-150 in an emergency setting is that without time to adequately triage patients, response workers wouldn't need to worry about killing someone with respiratory problems by giving them an opiod. Note, I am not a Dr