h********r
发帖数: 668 | 1 I knew a little about LUPUS since I did have a presentation about lupus many
years ago. So far no effective FDA-approved drugs specifically for lupus.
If HGSI's lupus drug can be approved, it will be first one. You know FDA's
panel committee recommended by 13:2 several days ago. On Dec 9, it will be
finally decided by FDA. The problem is that FDA has certain concerns about
suicide and efficiency.
My personal view is that FDA will ask more data for HGSI (positive signal)
or approve HGSI drug for lupus with certain limitations. I think that the
possibility of more data is ~30% and approving is ~70%. Rejection's chances
is 0.
I got some @24.09 and bought some calls today. |
t*******o
发帖数: 1464 | 2 这个你要问银杏，他是专家。
many
.
be
chances
【在 h********r 的大作中提到】
: I knew a little about LUPUS since I did have a presentation about lupus many
: years ago. So far no effective FDA-approved drugs specifically for lupus.
: If HGSI's lupus drug can be approved, it will be first one. You know FDA's
: panel committee recommended by 13:2 several days ago. On Dec 9, it will be
: finally decided by FDA. The problem is that FDA has certain concerns about
: suicide and efficiency.
: My personal view is that FDA will ask more data for HGSI (positive signal)
: or approve HGSI drug for lupus with certain limitations. I think that the
: possibility of more data is ~30% and approving is ~70%. Rejection's chances
: is 0.
|
y*****l
发帖数: 5997 | 3 银杏不在这里了。
还有大胖，生鱼片，小山。。。
【在 t*******o 的大作中提到】
: 这个你要问银杏，他是专家。
:
: many
: .
: be
: chances
|
h********r
发帖数: 668 | 4 Where are they?
Please do some comments!
【在 y*****l 的大作中提到】
: 银杏不在这里了。
: 还有大胖，生鱼片，小山。。。
|
b*****h
发帖数: 783 | 5 yes, i also think it is pretty safe to hold HGSI before PDUFA,
however, as everyone is expecting the approval of their dug, the delay or
asking more clinical data will tank stock price a lot in short time.
even FDA nods on their dug, the up space for HGSI is limited ( their Cap
already near 5B without any revenue).
So, I would be careful about whether betting on FDA's decision or not.
many
.
be
chances
【在 h********r 的大作中提到】
: I knew a little about LUPUS since I did have a presentation about lupus many
: years ago. So far no effective FDA-approved drugs specifically for lupus.
: If HGSI's lupus drug can be approved, it will be first one. You know FDA's
: panel committee recommended by 13:2 several days ago. On Dec 9, it will be
: finally decided by FDA. The problem is that FDA has certain concerns about
: suicide and efficiency.
: My personal view is that FDA will ask more data for HGSI (positive signal)
: or approve HGSI drug for lupus with certain limitations. I think that the
: possibility of more data is ~30% and approving is ~70%. Rejection's chances
: is 0.
|
t*******o
发帖数: 1464 | 6 我可以把银杏叫回来啊
【在 y*****l 的大作中提到】
: 银杏不在这里了。
: 还有大胖，生鱼片，小山。。。
|
h********r
发帖数: 668 | 7 Please
【在 t*******o 的大作中提到】
: 我可以把银杏叫回来啊
|
y*****l
发帖数: 5997 | 8 好的，你去请吧。
【在 t*******o 的大作中提到】
: 我可以把银杏叫回来啊
|
j*****7
发帖数: 4348 | 9 过了的话， 我认为收购价＜７B是很难相信的。
别的不说， 光lupus的药一年就能整上个1.5B的rev。 十几年下来还是很可观的。 这
还是把pipeline上别的compound都discount掉了的结果。 |
n****e
发帖数: 4990 | 10 他家的mm好像很黑， 不按常理出牌
【在 j*****7 的大作中提到】
: 过了的话， 我认为收购价＜７B是很难相信的。
: 别的不说， 光lupus的药一年就能整上个1.5B的rev。 十几年下来还是很可观的。 这
: 还是把pipeline上别的compound都discount掉了的结果。
|
|
|
M***m
发帖数: 762 | 11 是呀,上次盘后28.5X抢的,幸亏平推了.
后来24.5X买了一些,准备留到12/9.
【在 n****e 的大作中提到】
: 他家的mm好像很黑， 不按常理出牌
|
h********r
发帖数: 668 | 12 Did HGSI still have 1B cash?
【在 j*****7 的大作中提到】
: 过了的话， 我认为收购价＜７B是很难相信的。
: 别的不说， 光lupus的药一年就能整上个1.5B的rev。 十几年下来还是很可观的。 这
: 还是把pipeline上别的compound都discount掉了的结果。
|
h********r
发帖数: 668 | 13 I am waiting for counting the money.
【在 j*****7 的大作中提到】
: 过了的话， 我认为收购价＜７B是很难相信的。
: 别的不说， 光lupus的药一年就能整上个1.5B的rev。 十几年下来还是很可观的。 这
: 还是把pipeline上别的compound都discount掉了的结果。
|
j*****7
发帖数: 4348 | 14 Shouldn't be off too much, I didn't check burning rate though.
I paln to hold for 6 - 12 months, or even longer.
【在 h********r 的大作中提到】
: Did HGSI still have 1B cash?
|
D******9
发帖数: 2665 | 15 HGSI最经员工加班加点， 很多人八点以后才可以回家， 正准备弄FDA可能要的数据。
这个药的卖点是现今没有好的治疗方法， 问题是长期后疗效并不显著， 而且还有副作
用就像LZ说的。 |
h********r
发帖数: 668 | 16 Kind of Agree! I The critical point is that so far no drugs are available
for Lupus though HGSI only have moderate therapeutical effect. I think that
FDA will approve HGSI with certain limitations.
They tried everything to press the stock price. I have a strong feeling that
HGSI will be acquired soon (less than two months).
。
【在 D******9 的大作中提到】
: HGSI最经员工加班加点， 很多人八点以后才可以回家， 正准备弄FDA可能要的数据。
: 这个药的卖点是现今没有好的治疗方法， 问题是长期后疗效并不显著， 而且还有副作
: 用就像LZ说的。
|
g**********1
发帖数: 399 | 17 not a good sign for 12/9 approval. the data should have been included in the
submission, or some internal message for more data, but might be a
conditional approval. thanks very much for sharing.
。
【在 D******9 的大作中提到】
: HGSI最经员工加班加点， 很多人八点以后才可以回家， 正准备弄FDA可能要的数据。
: 这个药的卖点是现今没有好的治疗方法， 问题是长期后疗效并不显著， 而且还有副作
: 用就像LZ说的。
|
g**********1
发帖数: 399 | 18 why? from the charts?
acquire during the approval period or just after approval? 【 在 happymaker
(happymaker) 的大作中提到: 】 |
h********r
发帖数: 668 | 19 It is from my Gut feeling! FDA should ask more data from HGSI or approve it
with limitations. It doesn't make any sense that the price is so well
controlled. let's see what will happen.
happymaker
【在 g**********1 的大作中提到】
: why? from the charts?
: acquire during the approval period or just after approval? 【 在 happymaker
: (happymaker) 的大作中提到: 】
|
h********r
发帖数: 668 | 20 It is from my Gut feeling! FDA should ask more data from HGSI or approve it
with limitations. It doesn't make any sense that the price is so well
controlled. let's see what will happen.
happymaker
【在 g**********1 的大作中提到】
: why? from the charts?
: acquire during the approval period or just after approval? 【 在 happymaker
: (happymaker) 的大作中提到: 】
|
|
|
v**********m
发帖数: 5516 | 21 Why bother to buy this guy? I agree the points 生鱼片 made. |
h********r
发帖数: 668 | 22 I know HGSI is risky. Drug stock always have some risks. Just like AVNR,
most of people don't ecpect that it can be approved, but it was approved (I
had some stocks and several calls for that previously).
The following is what he said.
yes, i also think it is pretty safe to hold HGSI before PDUFA,
however, as everyone is expecting the approval of their dug, the delay or
asking more clinical data will tank stock price a lot in short time.
even FDA nods on their dug, the up space for HGSI is limited ( their Cap
already near 5B without any revenue).
So, I would be careful about whether betting on FDA's decision or not.
【在 v**********m 的大作中提到】
: Why bother to buy this guy? I agree the points 生鱼片 made.
|
n****e
发帖数: 4990 | 23 once again, their MM is very manupulaing
【在 n****e 的大作中提到】
: 他家的mm好像很黑， 不按常理出牌
|
f**********g
发帖数: 2252 | 24 HGS and GlaxoSmithKline announce extension of PDUFA date for SLE drug
Monday 12/06/2010 9:47 AM ET - Datamonitor
Related Companies
Symbol Last %Chg
HGSI 25.95 1.37%
As of 10:18 AM ET 12/6/10
Human Genome Sciences, Inc., or HGS, and GlaxoSmithKline PLC have announced
that the FDA has extended the Prescription Drug User Fee Act, or PDUFA,
target date for its priority review of the Biologics License Application, or
BLA, for Benlysta as a potential treatment for systemic lupus erythematosus
from December 9, 2010 to March 10, 2011.
After the FDA Arthritis Advisory Committee met on November 16, 2010 to
consider the Benlysta BLA, the FDA requested some additional information
from HGS, which has been submitted.
Belimumab is an investigational drug and the first in a new class of drugs
called BLyS-specific inhibitors. HGS and GSK are developing belimumab under
a definitive co-development and co-commercialization agreement entered into
in 2006.
http://www.datamonitor.com |
