With these new lows, big pharma could by eyeing NKTR like AZN to boost their portfolio after many of their patents expire. I wouldn't mind it if Howard sells for 12-15 PPS.
"Well and of course you missed that these patients have no other treatment options.... which part is worse please explain?"
We all reach a point where there are no further treatment options. Why is NKTR discussing safety if it doesn't matter in such cases? And why is the FDA concerned about such matters?
Well and of course you missed that these patients have no other treatment options.... which part is worse please explain?
Cuz I can't even fathom where your mind is..... I'm among the many.
>The major safety issue with cytotoxic agents is neutropenia. There is no convincing evidence that 102 shows improvement in that area even with the controlled patient population used thus far who were screened for tolerance. There was a continued significant incidence including severe cases and death. <
You must be unable to read..
• NKTR-102 is new and novel approach to treating patients with platinum resistant/refractory
ovarian cancer (PROC)
• NKTR-102 highly active in platinum resistant/refractory patients who previously received
treatment with PLD
• Confirmed response rate 19% for the q14d schedule, 21% for the q21d schedule
• Duration of confirmed response: 4.2 months/q14d, 4.4 months/q21d
• Median PFS (combined): 5.4 months
• Median OS (combined): 13.9 months
• Q21d schedule identified as the optimal regimen for Phase 3 testing due to better safety
profile than the q14d schedule. The most common treatment related Grade ≥ 3 toxicities
were late diarrhea and fatigue. Grade 4 toxicity was uncommon, occurring in only 1
patient in the q21 day schedule.
• No febrile neutropenia in the q21d schedule or clinically significant neuropathy in either schedule
• This study is currently enrolling an additional 110 platinum-resistant/refractory ovarian
cancer patients who have progressed after receiving PLD therapy to further evaluate single
agent NKTR-102 in this population with a high degree of unmet medical need.
• NKTR-102 is being evaluated in multiple cancer indications as a single and combination
agent. Phase 3 planning is underway in ovarian and breast cancers.
Conclusions: NKTR-102 shows evidence of clinical antitumor activity in combination with cetuximab. Toxicity is manageable; diarrhea and neutropenia are dose limiting. The recommended dose of NKTR-102 with cetuximab is 100mg/m2 every three weeks. Data support further evaluation of this combination in appropriate tumor types.
"While I'm not thrilled with the go it alone decision I don't see where the notion that the 102 results are dissapointing is coming from? They were not! They were and continue to be solid very good if you factor in safety"
The major safety issue with cytotoxic agents is neutropenia. There is no convincing evidence that 102 shows improvement in that area even with the controlled patient population used thus far who were screened for tolerance. There was a continued significant incidence including severe cases and death.
Cow, I respect your input and opinion but regarding your statement that:
"While I'm not thrilled with the go it alone decision I don't see where the notion that the 102 results are dissapointing is coming from? They were not! They were and continue to be solid very good if you factor in safety."
All along the plan for 102 was that it will be compared with Irinotecan to show that it was safe, had less side effects and was at least as effective as irinotecan. we Were also told or led to believe that once that is shown, approval of FDA will be thought through a partner (either fast track or phase 3). So if I assume that you are saying that was accomplished then why that plan is not being followed with or even without a partner and instead HR wants to spend $100M for a phase 3 for a sub group of cancer patients?
It seems to me and many investors who have either sold, shorted the stock, or are not buying NKTR that the reason was because, contrary to what HR said (whether it was his idea or Lorrianes, the buck stops at his door steps), the phae 2 results were not so good, and that was one reason a partner was not willing to pay much to partner 102.
To me data mining and finding a few patients who benefited from 102 and concluding that data warrants a phase 3 is absolutely crazy and IMHO indicative of a man (HR) who is not willing to face the truth and reality of the present situation.
I agree Cow the data is the data and the three Amigos talked very well of 102. As far as the OS data we have had zero info on that except that some still were on 102 from the phase I trials going into phase III ... with no other options..
While I'm not thrilled with the go it alone decision I don't see where the notion that the 102 results are dissapointing is coming from? They were not! They were and continue to be solid very good if you factor in safety. The issue isn't the drugs efficacy, it's the partnering/non-partnering decision, development strategy, and the finincial situation that can be legitimately questioned.
The notion that share price reflects reality in the short term is a bad premise. There are issues here that deserve explanation, but IMO the focus for investors should be on: Financials and development plans (they really go hand in hand since w/o PIII needs NKTR is actually on pretty solid ground for a while), and the apparent managment shuffling that has not been addressed. People are being paid good money as a group getting it right first time is not too much to ask. HR has been coming off as more of a BS artist than a solid leader of late IMO. If NKTR is at 20 in a few months people will be singing HR's praises even if it had very little to do with his actions, too much credit or blame for the guy in the big chair I guess that is always the way of things.
I hope he is put in the hot seat tomorrow and asked direct questions about their recent activities and statements... ie... "When you reconfirmed everyone that the decision to go it alone was because the data was so good, were you really talking about median OS from the 16 patient subpopulation?"