Re: Re: Gilead will acquire Calistoga and CAL101 - Karl

[Guest guest]

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? " , etc.

In a message dated 2/24/2011 9:06:19 A.M. Eastern Standard Time,

karls@... writes:

> 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).