Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Dianne Will's response is an embarrassment.

Dear Thomas,

In this instance, I think they are interchangeable.
This is my personal opinion (and I certainly don’t have the expertise as Nasrat in this area):

I personally use priority review. In my opinion, it may be that the FDA traditionally uses the fast track language and the priority review language has come out of the PDUFA Act. With the PDUFA Act, the FDA is mandated to provide a PDUFA date on when a company can expect a decision by the FDA following the acceptance of an NDA application. PDUFA dates for an NDA are normally a 10 month review cycle for a standard review or a six month review for a priority review. I think it comes down to Nasrat using FDA language and I use the PDUFA language.

IPCI recently also used the fast track language. We just did not issue a press release like IPCI did about not needing a Phase III and the fast track status. Obviously, things can change with the FDA.
However, I don’t doubt for a second that we won’t have a six month review. I believe there is too much of a precedent on this issue for the FDA to change course.

Best regards,
Dianne

What a bunch of gibberish. What is she talking about? It is disrespectful to a shareholder to provide this kind of response, which is demonstrably false in multiple regards. Can she not be bothered to take five minutes to educate herself? Anyone reading this could, in less than 30 seconds, find the appropriate page on the FDA website describing the difference between Fast Track and Priority Review. It's been linked to on this board multiple times in the past 2 days. Easy to find, clear concise language.


And Dianne, IPCI recently used Fast Track language in a PR because IPCI actually was recently granted Fast Track. Look it up...


http://www.streetinsider.com/Corporate+News/Intellipharmaceutics+(IPCI)+Granted+FDA+Fast+Track+Designation+for+Rexista+Oxycodone+XR+Development+Program/10594200.html

Intellipharmaceutics (IPCI) Granted FDA Fast Track Designation for Rexista Oxycodone XR Development Program

Intellipharmaceutics International (NASDAQ: IPCI) today announced that the United States Food and Drug Administration ("FDA") has reviewed the Company's request for Fast Track designation for its abuse deterrent Rexista Oxycodone XR (Oxycodone HCl) extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System ("PODRAS™") and has concluded that it meets the criteria for Fast Track designation.

I'm not a big fan of any I.R. and am suspicious of everything they say and do. And maybe it's not necessary for Dianne to understand these details in order to do her job effectively. But in my past experience, this kind of response is exactly what you can expect from Dianne Will: an unsophisticated understanding of the subject matter and a dismissive, condescending attitude toward shareholder concerns.