Why we have a winner for sure
Iressa was develop for the entire cancer population.
Turned out that it was effective but only for a small percentage.
Then years later then found out which group.
Cancer is now an example of personalized medicine. Getting the right drug for your specific genetic profile.
That was the 2009 ASCO theme, by the way.
Using genetic basically increases the odds for a compound to beyond 90% and close to 95%.
Let me explain myself.
FDA looks for 2 thing - safety and efficacy.
4601 is harmless, 26 patients in PI took it over a year and nothing was reported.
Another 20 patients took it for 4 to 1 year - nothing was reported and in this week conference call Seagal release that info again.
We got 1 out of 2 cleared. That's probably the most difficult hurdle for a cancer drug. managing side-effect.
Now efficacy.
Do we know if 4601 is efficacious?
We do, in lab test 4601 kills cancer cells.
In P1 6 out 7 patients got SD after 3 cycle and 4 out 7 after 6 cycles. That's about 3 monhts and 6 months SD for terminally ill patients that had less than 3 months to go. Dosage wasn't even optimal.
There is strong scientific data to say that YES 4601 works on cancer at large.
The last question that remains to be answered. On who is it affective?
With Caprion biomarker expertise + we can pretty much be sure that if someone can identify the sub-group it would be Caprion. Caprions does all that type of work for all the major pharmas.
So can Caprion find the sub-group - it will.
Last question - how big will the sub-group be and how lucrative it is?
This one is not difficult to answer. 4601 has been effective on anything related to EFGR and downstream from it.
Guess what 45% of the GBM population
Summing up:
Is it efficacious ? the answer is pretty much yes. The body of scientific evidence of tumor killing capacity is there.
On who is efficacious? EGFR mut
Can they find the sub-group? If caprion cannot, no one can 'cause they are the world expert on it. Thallion owns 20% of caprion and share the same office space.
Have a good Saturday and sit back and relax.
Market will react to this week awesome news.
It will take time becasue this is a micro cap.
But the above reasoning will sip in and form consensus.