h****n 发帖数: 37 | |
g****e 发帖数: 1426 | 2 估计都被震掉了。
在雅虎留言板看到的:
Bull thesis vs Bear Thesis
The Bull Case:
1. FDA BTD and Fast track - The only gene therapy company to receive both
2. 88% to 45% - Significantly lowered bar for approval
3. Using high dose mydicar vs placebo - In Cupid 1 it appears that even if
you took mid dose patients or low dose patients and compared them to the
placebo group, there were still significant reduction in events.
4. Serca 2 was found in biopsy data - They were in fact able to biopsy
patients that received the high dose of Mydicar and found gene expression in
these patients. Placebo, low and mid dose patients did not have gene
expression. This is a critically important point. The entire premise of the
science is that serca 2 is crucial to healthy hearts and that if we can
delivery serca 2 to the heart that will prevent incidents. I wonder if gene
expression is even higher in the patients that did not die.
5. Gene therapy is working - Gene therapy is working in all fields of
science right now from curing blindness ($ONCE) to Beta Thal and potentially
Sickle Cell ($BLUE)
6. Management - CEO is not a showman - Her bland monotone delivery is the
opposite of a CEO who is trying to pump the stock for fanfare so she can
sell her stock on an open market. She has consistently shown a great deal of
prudence in decision making as well as making preparations far down the
line. This is not a poorly managed company. She already has production deals
secured in both US and EU.
7. A Direct Line to the FDA - The FDA and CLDN have had multiple positive
discussions. It is very clear to me that the FDA has given CLDN very clear
instructions on what steps it needs to take in order to maximize the
potential of CLDN as well as to be prepared in the event that data is good.
I feel confident in saying the FDA told CLDN to proactively secure
manufacturing deals. Thus CEO is prudent and listens and executes whatever
FDA has told them to.
8. Delivery vector is the same as used by QURE - Qure's AAV1 vector is one
of the best and they already have app
9. Cupid 1 and Cupid 2 have extremely similar patient health characteristics
which CEO states in every conference call.
10. Extremely Safe - CEO stated that there have been no adverse effects
since following patients over 3 years since study initiation. Further, they
have stated that they might conduct trials with even higher doses if
necessary.
Bear Case -
1. Small study did not give enough sample size
2. Insider planned sales - These sales are planned and correlate with every
other action of this deliberate management
3. Placebo Patients were more sick - Study was supposed to be randomized and
I am sure the FDA wanted to hear more about how they randomized the tests
in the many discussions they have had. Nonetheless this is the one point
that I deem credible in the bear thesis. |
o******d 发帖数: 759 | 3 geroge大牛清仓了?还是清仓?
puts最近也有点异动
【在 g****e 的大作中提到】![](/moin_static193/solenoid/img/up.png) : 估计都被震掉了。 : 在雅虎留言板看到的: : Bull thesis vs Bear Thesis : The Bull Case: : 1. FDA BTD and Fast track - The only gene therapy company to receive both : 2. 88% to 45% - Significantly lowered bar for approval : 3. Using high dose mydicar vs placebo - In Cupid 1 it appears that even if : you took mid dose patients or low dose patients and compared them to the : placebo group, there were still significant reduction in events. : 4. Serca 2 was found in biopsy data - They were in fact able to biopsy
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E*********r 发帖数: 4984 | 4 这篇我看了,这人写得不错。样本少往往是被拿来作为一个看空的理由。心里话,样本
真不太好收,要求很高,而且Prospective去收的话价格很高。 Gene Therapy以前听起
来天方夜谭,但是现在随着转染机制的提高,这个做出来也没啥奇怪的。 如果FDA和
CLDN经常联络,也说明FDA比较看重该公司的产品。说实话,这更像是一个平台技术
Platform Technology。如果这个药物成功了,可以用相同的方法做其它的疾病。 |
d******e 发帖数: 27 | |
c*****e 发帖数: 1538 | |
B********n 发帖数: 384 | 7 我赌小,该怎么玩?.
【在 h****n 的大作中提到】![](/moin_static193/solenoid/img/up.png) : 多少人赌data?
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g*******e 发帖数: 3013 | |
s*********0 发帖数: 742 | 9 清了一半, 心情大好,明天准备清完,不过我一卖就涨, 大家明天接着买吧, 肯定
涨 |