粗说AVNR做老蛇的生日礼物（响应股帝）

colderdown

做药这行呢，炎症和中枢神经系统是两个很大的板块。但问题是对于这种慢性病，对药物的毒理要求就比较高，毕竟是一天得来点那中。对于中枢神经系统疾病，小分子（化合物）是目前唯一的选择，可惜太难，所以象LLY那样的大公司都不搞了,  对于炎症类，则是大，小分子都可以，小分子并无太多优势，除了口服的便利以外。这是行业特征，还有一点就是这类慢性病药，都要求比较大的clinic trail，很烧钱，FDA的要求也高。所以很少有小公司单干到底的，往往在一，二期就卖了，或者找大公司合作。AVNR现在的主要问题是临床实验出数据，死人了，现在还无法断定是不是跟药物有关，但起码AVNR没有否认。有人拿AVNR和DNDN比，我看是两回事。我当初在DNDN第一次申请失败前看过它的临床数据，主要问题是患者群不够到，统计上有风险，没买；但DNDN掉了以后，倒是买了些，因为它治癌症的方法是1st in class，可以一博，但也不敢多买，而AVNR呢，不是什么很新的target，又不象治癌药那样有优先权，所以一但临床有问题，拖也拖死了，太烧钱。所以我是不会去长期捂AVNR的，至于短期会怎么样，那是TA高手的强项。总之，玩生物科技，最好别上大的，哪怕是行内人，看走眼的都很多。I lost a BMW on ENCY.

逗你玩

yaobooyao

华佗股神！

colderdown

3# yaobooyao

不敢，保不齐AVNR明天就上10块，关键是数据了，大家小赌吧，别玩儿大了。

jc200900

同意。长期持有医药公司的个股就是赌博，一般是一买一大把做成基金比较安全。

BSW

Agree.  Another point on small biopharma company, if looking for long term investment, is to focus on its pipeline.  Many small companies live or die on just one potential drug.  For these kind of companies (which incude AVNR and the famed NBIX), holding for long term is like carrying a ball made of a half diamond and a half bomb.  The risk is simply too huge (the opposite side being the potential huge reward).

By contrast, the long term investing risk is much small if the companies have a deeper pipeline.  Examples of these companies include EXEL, and MEDX which was recently acquired by BMS.

In addtion to a deeper pipeline, a proprietary platform technology owened by a small company is another factor that could mitigate long term investing risk.  In this regard, MEDX is a notable example.  Its proprietary antibody technology is licensed by a majority of the big biotech and pharma companies.  Another example is companies which own the siRNA technology, such as ALNY and SIRNA (the latter company was acquired by Merck a couple of years ago).

baysky

Thanks for sharing.
There's some discussion/debate about the Death case on AVNR yahoo message board.
===========================================

Not only did it show efficacy at the 30/10 and the 20/10 trials, but there were practically no patients with SAE (serious adverse effect) related to the drug, Zenvia. The minor adverse effects were dizziness (19% and 11% for Zenvia 30/10 and 20/10 respedctively versus 6% in the placebo group), nausea (13% and 8% verus 9% for placebo) and diarrhea (10% and 14% versus 7% for placebo).

As for patients who discontinued the study: that was not related to the drug (8% and 18% versus 14% for placebo) I suspect that it was Zenvia's efficacy that was responsibl3e for the low discontinuation for the 30/10 group.

As for thr QT prolongation issue, that is no longer an issue. Avanir reported no cardiovascular side effects. On page 23 of http://b2icontent.irpass.cc/958%2F97729.... , the prolongation was 3.0 msec and -1.9 msec versus 1.5 msec for placebo. So it seems that if you measure the QT after 84 days, we see that the QT prolongation of 10.5 msec, seen earlier, can somehow auto-correct itself (cf homeostasis) after 84 days. SO THE QT PROLONGATION IS NOT AN ISSUE ANYMORE.

As for the 7 deaths, well, the study had 197 ALS patients who are suppose to die within 2-5 years after diagnosis. So according to published epidemological data, we expect 4-6% of the ALS patients to die irrespective of the drug. What we do see is 4.6%(3) and 4.4%(3) versus 1.6%(1) for the placebo. So what this tells us is that the placebo was a FLUKE. It msy be because that the patients in the 30/10 and 20/10 groups had more advanced ALS (avg. 23 months, avg, 16.3 months versus 13.4 months for placebo). So, as you can see, statistically, we may see patients in the 30/10 wing start to die within 1 month into the study, just becausae of the underlying ALS, and irrespective of Zenvia treatment. cf,, page 6 of http://b2icontent.irpass.cc/958%2F97627.... 6 of the 7 deaths were reported as not related to treatment. Most likely because the deaths occured after 5 days of treatment cesssation. There was only 1 death in the 20/10 group that MAY be treatment- related.

But overall, the STAR trial was a huge success for AVNR. There was no serious adverse effects and no cardio vascular side effects (becausse the QT prolongation is NOT an issue when you measure after 84 days). The deaths in the Zenvia trial wings were on the low side of what was expected for ALS patients. And the one death that MAY be treatment related--Well, we have to put things into perspective: these ALS patients are people who are living the last 2-5 years of their life. I would give them a drug that would make them happier, more sane and with more self-respect, even if it means that 1 out of 200 people who take the drug MAY die. Remember: they are scheduled to die anyways. At the absolute very worse, the FDA may approve for MS, Alzheimer's, Parkinson and brain injury, but they MAY not approve it for ALS patients. But that is the worse case scenario.

colderdown

read between lines:
"Remember: they are scheduled to die anyways. At the absolute very worse, the FDA may approve for MS, Alzheimer's, Parkinson and brain injury, but they MAY not approve it for ALS patients. But that is the worse case scenario."

My question is: Does AVNR has more money to go for another trail? Anyway, it is just my point of view. I don't own this one and have no plan to buy it either. There is nothing for sure in this bussiness, even for my DNDN. It may turn out to be paper money anyday as long as you still hold it. But it also may be gold someday.

股帝

鼓掌， 加油。 人人都这样，老子看都没时间啊！！

谷米

谢谢分析。俺对医药一窍不通，全凭看图。CERS上赚了一把，昨天卖掉，转手就迈勒AVNR，不承想今天就狗屎了。还好，比留着CERS到今天强。医药股可真锻炼人的神经。
图形上很难看了。3天之内，不管有美反弹，一定走人。除非量能突然爆起。不过前面那个大阴线，怎么看都难看。

jilier

dxzhu

Ding your opinion about AVNR! Thanks.

maimait

nice analysis, thanks a lot,

colderdown

10# 谷米
有时候看图比基本面管用。ENCY那一单，死了以后才明白做药也要政治挂帅，有空了讲讲，美国也很黑。

Cobra

Thanks!

dfw

Thanks

coexist

thanks

tape

ency 俺的心痛

happyface

baibai

Hope to read more your analysis on biopharm stocks. Recently another small biopharm company died (RPRX). It is not dead cat rebounce.