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Opinion question: which biotech has the most novel unpartnered (post PoC ) compound in development?
"As CMS reimbursement kicks in, FMI’s revenue split should move...."
When do you expect that to happen?
<You have to give PBYI management enormous credit for designing this creative adjuvant trial >
I thought they inherited the trial design from Pfizer. Also, I thought the design was due to the tox profile of neratinib--as it was too toxic to be combined with Herceptin in an adjuvant setting.
Someone on the board knows the answer to my next question- is two years of Herceptin better than one year of Herceptin in the adjuvant setting? The only comparisons I am aware of is six months vs one year.
Provenge: That fits! Great example. Thanks.
OGXI: Can anyone post recent examples of Oncology drugs that did not meet the interim efficacy hurdle (75% of planned events), but did meet the final efficacy requirement?
It's hard to compare. The ibrutinib patient pop failed chop-Rituxan (with or without Rituxan maintenance) and potentially velcade (50 of the 115 pts). OR was 68%, CR - 21%, PFS - 13.9 mo
http://www.nejm.org/doi/full/10.1056/NEJMoa1306220
A better comparison might be velcade in a similar (slightly less heavily pre-treated pop)--TTP -6.7 mo
http://www.ncbi.nlm.nih.gov/pubmed/19074748
T351i mutation? Really? Did she really write that? I understand the rush to get these reports out, but that is hard to miss.
I am confused about the market reaction to the announcement. How is this a good thing for shareholders?
If I were a BP I would make a 2 bil hostile offer (if necessary) and run all Ponatinib trials at 30/15 mg (45 where necessary) and you would have a very nice ROI in a reasonable time.[/i]
I would bet CELG and a few others are running the numbers/models as we speak.
Have NVS and INCY done anything to make it hard or foolish to split tablets?
I don't know.
ARIA dosage:
Found the info---the 15mg is half the price of the 45mg, so at the 30mg dose, there is no impact on sales. At the 15mg dose, there would be a significant impact on sales.
Flat (or close to it) pricing exists for many TKIs in the US. Jakafi and Afinitor come to mind as examples.
ARIA - dosage strengths:
Does anyone know how Ariad is pricing their two tablets: 45mg and 15mg? Are they using flat, linear or some hybrid? Is the US different from the EU? i.e. Flat in the US and linear in the EU.
Inclusig will likely be second line if pt fails tasigna
The DC rates for the ABLs are close to 20% and the AE profiles are different enough that I think Iclusig will still get use. The uptake curve, however, will likely become more shallow - closer to the original nilotinib uptake curve.
ARIA: getting crushed pre market. I literally just picked up some shares yesterday.
Not sure how far you want to go back, but BMY had an oral 5FU that was recommended by ODAC and rejected by the FDA. Happened in the late 90's / early 2000's if I recall correctly.
Biased because I worked on the global launch plan in 11/12 (as did a large number of internal NVS and external agency/vendors).
My guess is transplant sales growth is relatively flat. Certican in some EU countries is being used in oncology indications due the large price difference (10 1 mg Certican tablets cost is much lower than 1 10mg Afinitor tablet in all/most EU countries). I would still submit that most of the growth in sales is due to the ER+ BC launch.
I might be biased on this answer, but would guess most of it (especially when you consider RCC share declined, TSC sales were de minimis and pNet was weak at best)
It is still not clear to me how they arrived at the dose/concentration they are using in phase II.
Mike Hawkins, the former CMO at Abraxis moved there years ago to help build their oncology pipeline. He's a direct and smart guy.
Maybe you can help me. How did they go from preclin straight to PhII? Are they assuming (or modeling) a dose (or concentration) from their preclin work? Is this normal for optical solution product development?
Lapatinib in combination with Let (AI in EU) in ER+/HER2+ mBC.....the overall trial was negative. The caveat is PFS in the pre specified subset was the primary endpoint of the study.
PoC = Proof of Concept
Dew- can you disclose how you are playing this trend?
<costs about $23,000 per month of survival, which is similar to Taxotere (when you take into account supportive care/premedication).>>
Care to break down those costs?
Agree.........I find it interesting that Roche has yet to make public the durability of response for all the responders in that trial. If the responses were durable, then I think the FDA would be hard pressed to RTF (unless there was a high percentage of missing scans or some other data management issues).
<<Where you and I differ is that I won't pass on the opinion pieces of a proven and habitual liar.>>
"If you can't answer a man's argument, all is not lost; you can still call him vile names."
Life Expectancy:
But if you remove homicides and accidents from the raw data, the US goes to number one.
http://mjperry.blogspot.com/2007/11/beyond-those-health-care-numbers-us.html
jbog-
All valid points. Too bad these are not included in this admin's current discussion on healthcare.
On another topic- what companies are you currently looking at in the oncology space?
Current holdings include: ARIA, ARQL, ANLY, CRGN,ELN,EXEL,JAV, MEDX, MNTA
I am quite fickle in this sector. It has cost me by selling too early with SPPI, CGRB and MDVN.
One potential problem with the data is that the majority of the patients did not receive SOC (Chop+R) as 1st line therapy.
Another could be the use of maintanence R after 1st line.
Congrats on your gain- exwannabe.
I sold earlier this year after SPPI broke $2 (to the upside)for what I thought at the time was a nice gain. I was concerned that Zevalin sales would disappoint, due to competition from Treanda in the salvage NHL setting and that 1st line -consolidation would not be as big as some were expecting after attending a Hem conference in Whistler in Feb. In retrospect, I should not have gotten scared out of the stock.
Congrats again.
http://www.huffingtonpost.com/2009/05/14/dead-people-get-stimulus-_n_203794.html
Your tax dollars in action.
Thanks Dew.
Could whoever posted the list of biotechs with negative enterprise values post the list again?
Avastin ODAC: Biostats
The reason there were two biostats guys on the panel is that the trial results were a mess. A lot of missing scans (so how do you really know when a patient progressed?) and a very high discordance rate between the IRF and the investigator reported numbers. The missing scans were not as bad as when IMCL got the RTF letter from the FDA, but it was an issue.
"ECOG and IRF were discordant for 368 (181 in PAC arm and 187 in PAC/BV arm) patients, which accounts for 51.0% of the 722 patients."
During the Q&A, the tone of the questions from the panel were very negative. I thought Avastin would only get 2 postive votes based on the questions asked by the panel members. Also, Eric Winer (speaking on behalf of DNA)and Maha Hussain got in to it one time, with Dr. Hussain getting the better, IMO.
Winer brought up that Ixabepilone was approved (albeit for 2/3rd line MBC) with a smaller benefit and a lot of PN toxicity. Hussain responded by saying it was a weak argument to use one "substandard" trial to justify another "substandard" trial. Winer then sat down.
Hussain, then turned to Padzur and said she wished the panel had the opportunity to review Ixabepilone prior to the FDA approving it. My take was that she thinks very little of the Ixabepilone data.
Thanks. eom
<<How much is a life worth?>>
Do you have a link to this article?