Replies to post #203210 on Elite Pharmaceuticals Inc (ELTP)

[sharkey1]

Thanks Lasers, I'm on pins and needles, I may have to join Snup, and after it's all over Ck. in to A Betty Ford, LOL

[lasers]

From the ALO-02 review it is encouraging that ALO-02 has increased the Naltrexone ratio vs Embeda ALO-01

ALO-02 capsules are hard gelatin capsule shells filled with
pellets from a single common formulation to achieve the dosage strengths of 10 mg/1.2 mg,
20 mg/2.4 mg, 30 mg/3.6 mg, 40 mg/4.8 mg, 60 mg/7.2 mg and 80 mg/9.6 mg oxycodone
HCl/naltrexone HCl dosage strengths, respectively. As illustrated in Figure 1, the ALO-02
pellets consist of inert seed cores coated with multiple drug and polymer layers in which ER
oxycodone HCl surrounds sequestered naltrexone HCl.

However more reading is required as to the vulnerability of separating the Oxycodone and Naltrexone with different solvents.

[Jimmy Joe]

Okay.. Ill take a shot. Lasers would it be better for Elite if ALO-02 is given a PDUFA? Or if stability of the product is the only issue for ALO-02 it would not really matter in Elite's case?
Elite would be able to use all other ALO-02 data as a comparator since Elite's stability is ROCK SOLID.


Bottom line: Approval for ALO-02 better for Elite or not in your opinion?
Thanks