Re: Gilead will acquire Calistoga and CAL101

[Guest guest]

Does this indicate a faster pace for

commercial development of CAL 101?

[Guest guest]

> Does this indicate a faster pace for

> commercial development of CAL 101?

My guess is that this is an encouraging development. CAL101 wouldn't have a

buyer if it was not considered promising. The buyer, in such cases is typically

a company with the assets needed to carry out the expensive clinical research

and do the marketing and manufacturing if the results of its primary study is

persuasive.

Remaining issues affecting the pace (for this or any new agent): what study

design for the application for marketing approval; how the study design might

influence study enrollment rates (randomized studies can be slow to accrue)....

and the result of the study and how long it takes to measure the results.

.... The final step is manufacturing - the company has to be able to produce the

approved product on a new scale with acceptable manufacturing practices.

I think it's important to spell out the reasons why it takes so long for new

drugs to become available in the clinic ... so we can make informed choices now

.... (that is, for the foreseeable future, access to new agents is possible only

in clinical trials and approvals - assuming everything goes according to plan --

could be 5 years or more away).

[Guest guest]

At 02:35 PM 2/24/2011, jb50192@... wrote:

>Don't forget the FDA and their rules on " is it needed " , " does it

>really make a difference " , don't we have something like this already? "

Are these official, publicly published or presented rules (or

guidelines) for CAL-101 (and other new CLL drugs)? or are they

unofficial discussions between the FDA and the drug sponsors (e.g. Calistoga)?

Al Janski

[Guest guest]

My understanding is that these are published, I have not read them exactly,

but they are generally hurdles you have to overcome.

In a message dated 2/24/2011 3:44:46 P.M. Eastern Standard Time,

aljanski@... writes:

At 02:35 PM 2/24/2011, _jb50192@..._ (mailto:jb50192@...) wrote:

>Don't forget the FDA and their rules on " is it needed " , " does it

>really make a difference " , don't we have something like this already? "

Are these official, publicly published or presented rules (or

guidelines) for CAL-101 (and other new CLL drugs)? or are they

unofficial discussions between the FDA and the drug sponsors (e.g.

Calistoga)?

Al Janski

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