Pharmacyclics Inc. Message Board
-
BREAKTHROUGH DESIGNATION will
be done by the FDA as soon as they work out the details of the phase 3 trials. BET ON IT !
-
What do you think our next big cataylst will be and time frame? we got europe stuff june 16th? Any other timeoline you see where PCYC can explode
- 1 Reply to comstockcir
-
buy and hold
-
There is a process and the new FDA user fee bill shortens specific designed phase three trials in order to bring Breakthrough Drugs to market quicker to an unmet class. Ibrutinib already has proven that. In so many levels.
-
Best drug going in the whole biotech field and who in their right mind thinks the FDA is just sitting on it.
- 1 Reply to popeyethesailor61
-
Yes.Many drugs have been approved after phase II, with the caveat that the companies continue their ongoing trials to gather data on safety and efficacy.http://jco.ascopubs.org/content/27/36/6243.abstract And i am sure you remember this: Pharmacyclics Conference Call Script March 15, 2012 I like to know about fast tracking of speeding up the process of getting approval and it getting to market. Any of the particular drugs especially the one that’s going into phase 3.
Lori Kunkel:
So, certainly for fast track, we meet the criteria for fast track approval and that would be part of our strategy, Alice can speak to the details of the with what would be required.
Alice Wei:
So basically as you are probably well aware of that fast track is a development of a drug and a clinical development program so it would be per therapeutic oncologic program or indication disease such as CLL, MCL so on so forth. So you are correct if this is a good candidate for fast track designation by the agency and it is a good candidate that we are having that within our plan looking for consideration so at this point time all I can say is stay tune and you’ll be hearing more about that in the near future.
-