Search found 367 matches

by biopearl
Wed Mar 21, 2018 4:34 pm
Forum: ImetelChat
Topic: Repost from SA re FDA- see MTBs excellent article
Replies: 0
Views: 2055

Repost from SA re FDA- see MTBs excellent article

biopearl Comments (576) |+ Follow MTB, this is exactly the problem with the FDAs failure to approve on what appears to be overwhelmingly positive data because of the absence of a traditional control arm. Because of the structure of the R/R study the "control arm" relies on historical data which is a...
by biopearl
Wed Mar 21, 2018 4:23 pm
Forum: ImetelChat
Topic: EMA Prime
Replies: 4
Views: 8440

Re: EMA Prime

Fish, agree completely. Jpheis, I interpreted JS comments a little differently (not to say I wouldn't love to see early EU approval first) but his comments about how MDS is treated in Europe suggested that they were targeting Europe for front line MDS therapy. I did not get a sense that he was sugge...
by biopearl
Tue Mar 20, 2018 8:07 pm
Forum: ImetelChat
Topic: Will insurance coverage only be provided for R/R MF patients based on the current CT?
Replies: 5
Views: 4713

Re: Will insurance coverage only be provided for R/R MF patients based on the current CT?

Hunt, I don't think this drug will be off label for long. Even in the current indications being studied the market is substantial. Re dealing with insurance companies--you can be sure J and J has an army of beaurocrats familiar with the process including a strong legal team. No insurance company wan...
by biopearl
Tue Mar 20, 2018 5:07 pm
Forum: ImetelChat
Topic: OS vs median OS
Replies: 1
Views: 4250

OS vs median OS

Additional thoughts: One thing to keep in mind as we try to parse out what Dr. S actually meant with his comments which were as noted in discussion here-opaque. OS is how long patients live from the time of enrollment or treatment initiation (or possibly from the time JAK inhibitor stopped, we don't...
by biopearl
Tue Mar 20, 2018 12:21 am
Forum: ImetelChat
Topic: Take aways from today's cc
Replies: 5
Views: 4920

Take aways from today's cc

In the interest of parsimony I will summarize my thoughts in as few words as possible. Several board members in other forums have requested that I do so butI I think most of what I say has been discussed among many excellent posters. Fish has asked that I assume a co moderator position on his very e...
by biopearl
Mon Mar 19, 2018 8:54 pm
Forum: ImetelChat
Topic: SA is becoming increasingly useless
Replies: 3
Views: 3226

Re: SA is becoming increasingly useless

I would definitely not pay SA anything. The value is really in the discussion and sharing of information that follows the articles. There have been some excellent articles which (MTB, Hoosier Investor, OOI, CKTC) can be accessed for 30 days. I expect SA to change that for the worse . That is why thi...
by biopearl
Sun Mar 18, 2018 5:19 pm
Forum: ImetelChat
Topic: Will insurance coverage only be provided for R/R MF patients based on the current CT?
Replies: 5
Views: 4713

Re: Will insurance coverage only be provided for R/R MF patients based on the current CT?

Hunt, I think it won't be hard for insurance companies to analyze saved hospital costs (fewer blood transfusions, longer life, less anemia, no JAK meds etc--don't know about impact on hospice/end of life effects--but you can be sure actuaries are at their calculators. What they will find it Imetelst...
by biopearl
Sun Mar 18, 2018 3:39 pm
Forum: ImetelChat
Topic: Question to pose
Replies: 3
Views: 2563

Re: Question to pose

You are right about that. The Janssen "skunk works" lab studies have probably opened many doors which remain unknown to us. Judging by the last patent filing many many doors. bp
by biopearl
Sun Mar 18, 2018 1:58 am
Forum: ImetelChat
Topic: Question to pose
Replies: 3
Views: 2563

Re: Question to pose

Dogonenuts, you are WAY ahead of yourself. There will be not combination therapy until there are studies to support this approach. There might not even be front line single therapy in MF without further study (some info available from Mayo) but unless physicians use the drug off label which they mig...
by biopearl
Sat Mar 10, 2018 6:16 pm
Forum: ImetelChat
Topic: Fish, new patent re combination Imet and Venetoclax
Replies: 0
Views: 2776

Fish, new patent re combination Imet and Venetoclax

Fish, lots of discussion on SA and YMB re new Janssen patent re combination Rx for multi hematologic malignancies, might be worth posting the patent here for discussion. This was my last post: How many times have we seen patents filed only to languish in the patent office (Einstein doesn't work ther...
by biopearl
Sun Feb 11, 2018 7:31 am
Forum: ImetelChat
Topic: Current 1Q18 MF median OS review and related upcoming reporting
Replies: 7
Views: 5833

Re: Current 1Q18 MF median OS review and related upcoming reporting

Sorry hunt I initially didnt not realize you were the author of the query to Anna. That’s the most detailed reply I have seen. Thanks for your efforts. Honestly, the reply was a little disingenuous in that while yes OS data has not matured, surely surrogate data must be plentiful. CRs, PRs CIs to st...
by biopearl
Sun Feb 11, 2018 12:33 am
Forum: ImetelChat
Topic: Current 1Q18 MF median OS review and related upcoming reporting
Replies: 7
Views: 5833

Re: Current 1Q18 MF median OS review and related upcoming reporting

Dog, I completely agree, we should at least be apprised as to how many patients remain in study and on drug. Fish, thanks for trying to get further info. That the normally subtle and subdued Anna has become voluable may be no accident and may presage a more open approach to investors, that would be ...
by biopearl
Sat Dec 30, 2017 9:09 pm
Forum: ImetelChat
Topic: Happy 2018!
Replies: 1
Views: 2396

Re: Happy 2018!

Back at you,fish and best wishes for a healthy and prosperous New Year for. Thanks for the many thoughtful contributions to this board and special thanks to Fish for being the driving force for this forum. bp
by biopearl
Tue Dec 19, 2017 11:12 pm
Forum: ImetelChat
Topic: Imetelstat MDS Poster at ASH2017: PR's and CR's
Replies: 4
Views: 4313

Re: Imetelstat MDS Poster at ASH2017: PR's and CR's

Fish, for completeness, you might want to append CKTK's response to Hoosier. Each one of the two are easily the most respected contributors to the SA Geron board. CKTK makes the point that the dose reduction was required to manage the cytopenias induced at the higher dose. Hoosier graciously acknowl...
by biopearl
Wed Dec 13, 2017 7:49 pm
Forum: ImetelChat
Topic: Dr. Raza
Replies: 9
Views: 8996

Re: Dr. Raza

Fish, that should read "any other disease modifying therapies". Sorry
by biopearl
Tue Dec 12, 2017 11:44 pm
Forum: ImetelChat
Topic: Dr. Raza
Replies: 9
Views: 8996

Re: Dr. Raza

Fish, you might want to link the Dr. Raza TedX talk. Next Tuesday's presentation should be interesting. Even though the TI bar is high, a look at HI and transfusion reduction may translate into an improvement in prognosis as well. So far I am unaware of any disease modifying therapies. In theory by ...
by biopearl
Fri Dec 08, 2017 7:24 pm
Forum: ImetelChat
Topic: Dr. Raza
Replies: 9
Views: 8996

Dr. Raza

As most know, Dr. Raza is the second author on the MDS abstract to be presented Monday at ASH. She will be representing the authors at an investor meeting the following week in NYC (see Geron PR) to discuss the abstract findings which as we have discussed are quite remarkable in a disease that has n...
by biopearl
Thu Nov 23, 2017 6:26 pm
Forum: ImetelChat
Topic: BTD represents a paradigm shift at the FDA
Replies: 1
Views: 2626

Re: BTD represents a paradigm shift at the FDA

Sargasso, this is (another one of your) great finds. Thanks for sharing. There is certainly a reasonable likelihood of BTD in R/R MF. bp
by biopearl
Wed Nov 22, 2017 7:16 pm
Forum: ImetelChat
Topic: Thoughts on this week's presentation
Replies: 7
Views: 6077

Re: Thoughts on this week's presentation

Reference courtesy of Sargasso:
http://bit.ly/2jP8aPy
by biopearl
Tue Nov 21, 2017 2:52 pm
Forum: ImetelChat
Topic: Thoughts on this week's presentation
Replies: 7
Views: 6077

Re: Thoughts on this week's presentation

My apologies for getting anyones hopes up unnecessarily. There is no late breaker I can find. Since FDA did ask for information I hope the conclusion that it was to evaluate for accelerated status is correct. Best wishes, bp