Biotech Values

[zigzagman]

Will ANX-530 be eligible for Priority or Fast Track Status or NOT?...

When the company PR's the FDA's decision on it's NDA next week...

While most of us on IHUB know what a zoo the Yahoo message boards are, and avoid them like the plague for the most part, every once in a while a thread gets started there that is extremely interesting and gets right down to the important issues...

This is just such a thread:

http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=te&bn=1150&tid=124134&mid=124134&tof=4&frt=2#124134

In it 'mqwlaser' is absolutely sure that there is NO WAY 530 will qualify for an accelerated status...The rebuttal is from 'dancyquan' who is quoting his information directly from an official FDA pdf file:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126637.pdf

About two thirds of the way towards the bottom of this thread is where it gets interesting...It is a discussion about if ANX-530 will be eligible for Priority or Fast Track Status when the FDA accepts it's NDA...While the most common definition is the new drug "must fill an unmet need", the definitions found in the pdf show that there may be a possibility that 530 could qualify for an accelerated status...

Here's a quote from 'dancyquan' that specifies what area of the pdf file he's getting his information from...I have scanned that part of the document, and he is quoting it correctly:

Laser..Excuse me but here is the FDA definition of "unmet medical need" defined in the FDA Guidance for Industry-Available Therapy Part III (D):

..the agency defined an unmet medical need as a "medical need that is not addressed adequately by an existing therapy."

Of course, a 30% injection site reaction by users of Vinorelbine might well fit that definition..wouldn't you think?

Continuing, the language states:

"Where there is available therapy for the condition the drug development program would address unmet medical needs if it evaluated any of the following:"

(.)Improved effects on serious outcomes of the condition that is affected by alternative therapies.

Among other things focus on this..It states:
..(.)"Ability to provide benefits in patients who are unable to tolerate or are unresponsive to alternative agents, or ability to be used effectively in combination with other critical agents that cannot be combined with available therapy.

(.) Ability to provide benefits in patients who are unable to tolerate or are unresponsive to alternative agents..."

(.)Ability to provide benefits similer to those of alternatives, while avoiding serious toxicity that is present in existing therapies, or avoiding less serious toxicity that is common and cause discontinuation of a treatment of a serious disease."

(.) Ability to provide benefits similar to those of alternatives but with improvement in some factor, such as compliance or convenience, that is shown to lead to improved effects on serious outcomes."

The Piority Review policies in (E) and Part IV are even more definitively in favor of a preferred review of 530..

So, I'm confused as to the basis for your conclusion...especially one so clearly poured in cement when in fact the FDA Guidance is in direct conflict with your position.

What do you think DD?...Your thoughts are always appreciated...TIA