DID YOU KNOW THAT in platinum refractory/resistant ovarian cancer patients, based on PUBLISHED trial data, the median progression-free survival (PFS) for DOXIL is ONLY 9.1 months and the median survival is JUST 35.6 weeks. SO WHAT CHANCE COULD DOXIL POSSIBLY HAVE COMPETING AGAINST TELCYTA+CARBO IN ASSIST-3?
The ASSIST-3 phase III trial enrolled 244 platinum refractory/resistant ovarian cancer patients where 122 patients were treated with the combination of TELCYTA and carboplatin and 122 (the control group) were treated with Doxil (standard therapy for 2nd line treatment of NSCLC). The primary endpoint of the trial is the objective-response rate and the secondary endpoints are the median progression-free survival (PFS) and median survival. ASSIST-3 began enrollment in DEC-2004 and finished enrolling in Q1 (~mid-Feb) 2006.
Since ASSIST-3 IS STILL ONGOING, the patients have SO FAR been in the trial from 37 weeks to 98 weeks, BUT THE TRIGGER EVENT HAS NOT BEEN REACHED YET.
Thus, in ASSIST-3, most of the Doxil group patients have passed away while the TELCYTA-TREATED patients have not even reached their median PFS yet. Moreover, according to Wick (in the CC), TELK may not even have MATURE PFS data by the yearend, which suggests VERY LONG MEDIAN PFS (far better than the Doxil trial, which had mature PFS data after just 30 weeks).
NOW, when Birchenough asked whether TELK was planning to include PFS data in the NDA for TELCYTA, WICK answered that TELK was not planning on it but since the median PFS for Doxil is only about 9 weeks, many UNFORTUNATE EVENTS may take place by JULY 2007, when the NDA will be ready. Wick was referring to the expected UNFORTUNATE deaths of the Doxil-treated patients (control group). The Doxil survival data (median survival of 35.6 weeks) indicate that by July-2007, very few (if any) of the control-group patients would remain alive.
For comparison, in phase II, the treatment of platinum refractory/resistant ovarian cancer patients
with TELCYTA and Carboplatin RESULTED IN an OBJECTIVE RESPONSE RATE OF NEAR 60% AND A DISEASE STABILIZATION RATE OF NEAR 90%.
What many analysts DO NOT GET is the strong effect that high objective response rates have on survival. Birchenough made a reference to a comparison of Hycamtin to Doxil where Doxil had a higher objective response rate (12.3%) than hycamtin (6.4%) but had a lower median survival (35.6 weeks versus 41.3 weeks). Birchenough forgot to look at the DISEASE CONTROL RATE (objective responses + stable disease), which has a direct correlation with survival. Hycamtin had a disease-control rate of 49.1% whereas Doxil had a disease control rate of 40%, which explains the slight improvement in survival (5 weeks) due to Hycamtin.
BUT AGAIN, IN PHASE II, TELCYTA HAD A DISEASE-CONTROL RATE OF NEAR 90% AND AN OBJECTIVE RESPONSE RATE OF NEAR 60%. This suggests that the median survival will not be reached by the time the NDA is filed with the FDA but nearly all of the Doxil patients will have passed away. ONE CANNOT GET MORE IMPRESSIVE ASSIST-3 DATA FOR THE NDA -- MOST TELCYTA-TREATED PATIENTS STILL ALIVE WHEREAS NEARLY NONE OF THE CONTROL-GROUP SURVIVED.
In such a case, FDA APPROVAL OF TELCYTA, in BOTH 2nd line (ASSIST-3) and 3rd line (ASSIST-1) treatments of platinum refractory/resistant ovarian cancer patients, will undoubtedly be CLEAR to all analysts after the DATA is made public by yearend. At that time, FDA APPROVAL will in all likelihood be viewed as a CERTAINTY. And the price of TELK should reflect that INSTANTLY. I am looking for an OSIP-LIKE DAY after the announcement (on APR 26, 2004, OSIP jumped from 38.14 to 91.10 on news that its Tarceva p3 data showed a slight improvement in survival over std. therapy).
It will all be history soon!!
>i had plenty of margin and was only buying 700 shares i was in another country(TURKEY} and figured that was the problem<
I think you nailed it... that *was* the problem. You should have been out having doner kebap and drinking coffee and raki rather than buying Telik. Your computer was trying to tell you something.
i had plenty of margin and was only buying 700 shares i was in another country(TURKEY} and figured that was the problem but later in the day i tryed again and it went through after failing twice. who knows. one other thing once i had the laptop and desk top going at the same time and went i pushed to engage in a buy the last ticks turned green on that stock on the other computer the ticks stayed red.the only tick on the trading platform that changed was the one i wanted to buy. they see you wanting to buy and they give you green ticks,i took a picture of the screen at the same time.so who knows what goes on.
Look the stock is very liquid for small trades. Unless you were trying to buy or sell a big block I have to assume it was technical difficulty.
But many brokers do have special margin requirements for TELK. Were you buying on Margin? You might find it hard to margin more than 50% of your position.
Fail-to-deliver simply means the broker has an imbalance in the equity (a naked short imbalance). They will force you to buy in, or charge a fee to locate stock so you can stay short.
Had a friend with a large position in BPT who was contacted by a broker who wanted to borrow his stock. Seems there was a large interest in shorting BPT a while back. And there was very little stock availble for shorting. So they went out and found some, and they were paying good money if you loaned your share. Same thing may be going on with TELK. Borker can make good money keeping his clients short.
"Since ASSIST-3 IS STILL ONGOING, the patients have SO FAR been in the trial from 37 weeks to 98 weeks, BUT THE TRIGGER EVENT HAS NOT BEEN REACHED YET"
Seems I recall Bianco using the same "evidence" as proof xyotax worked. Hmmmm, that did not go over too well, now did it.
<<Seems I recall Bianco using the same "evidence" as proof xyotax>>
I don't know who Bianco is or what xyotax could do BUT if you based your decision to short-sell TELK because you saw similarities in some other realm, YOU ARE ABOUT TO SEE A SHORTING LOSS that is FAR BIGGER THAN YOU HAVE EVER HAD.
Just look at the data for the phase II trial of TELCYTA + CARBOPLATIN IN PLATINUM-RESISTANT ovarian cancer PATIENTS. HOW ABOUT AN OBJECTIVE RESPONSE RATE OF 54% (vs. 12% for Doxil) and a median PFS of 25.5 weeks (vs. 9.1 weeks for Doxil).
Thus, if the results of ASSIST-3 are similar to the above results of the phase II trial, AND IT NOW APPEARS THAT THEY MAY EVEN BE BETTER (causing the CEO and COO to buy TELK shares on the open market <very UNUSUAL>), APPROVAL OF TELCYTA WILL BE UNSTOPPABLE.
CAREFULLT think about which side of TELK you'd rather be on then.
It will all be history soon!!
<< DID YOU KNOW THAT in platinum refractory/resistant ovarian cancer patients, based on PUBLISHED trial data, the median progression-free survival (PFS) for DOXIL is ONLY 9.1 months >>
CORRECTION: THAT's ONLY 9.1 WEEKS.
Hard to believe? look in the following link:
In your previous post you said that if Telik does not meet the endpoints the stock goes to 3.00. Here you say that if positve results are announced the stock goes up 25%(23.00) This seems like a bad bet to me. A 5.00 gain versus a 15.00 loss. Does this reflect your opinion that positive results are 3 times as likely?