The number of cases increased abruptly in the third phase of the clinical stage is 160, and the opinions of the shareholders are different, so it is highly suspected

On November 6, step pharmaceutical released the announcement on signing the supplementary agreement of clinical research technical service contract Shandong Danhong Pharmaceutical Co., Ltd (hereinafter referred to as "Shandong Danhong") and Beijing Kangrui Xinhua Technology Development Co., Ltd (hereinafter referred to as "Beijing Kangrui Xinhua") signed the "pth1-84iii recombinant human parathyroid hormone" Phase III clinical trial technical service contract of recombinant human parathyroid hormone PTH (1-84), which was signed in February 2014, was supplemented The specific operation increased the number of cases from 480 to 640, 480 in the experimental group and 160 in the control group At present, the trial plan with the number of cases increased to 640 has obtained the ethical approval of the team leader In order to ensure the smooth progress of the trial, it is necessary to supplement the researcher observation fee, inspection fee, subsidy for the subjects and the service fee of cro company and other related expenses of 160 subjects In the announcement, step pharmaceutical also stated that this time Shandong Danhong signed a supplementary agreement of clinical research technical service contract with a third party, which is conducive to expanding the company's drug research and development capacity and scope, to a certain extent, saving the time and cost of the company's drug clinical trials, and ensuring the smooth progress of the project The contract amount of this clinical trial will not have an adverse impact on the company's financial situation and operating results However, as of 11:10 on November 6, stepstock did not increase but decreased, which was astonishing Netizens' previous guesses have also been initially confirmed Of course, now they are only showing a short-term phenomenon, and how to do it is yet to be verified The quarrel among netizens is increasing instead of decreasing As a melon eater, follow me to watch Net friend a: this announcement is a negative for the stock market, which is a huge negative! It is equivalent to declaring phase III clinical trial failure in disguised form and increasing cases to try to save This week may be down to 3 Netizen B: medicine is a very serious matter How many cases can reach statistical conclusions? It was made at the beginning of clinical trials Now, increasing cases halfway means that things have changed From the perspective of enterprises, 480 cases can make results Why spend so much money to do it? So abnormality is the demon Netizen C: Generally speaking, after phase II passes, the success rate of phase III is relatively high, about 60% So the risk of this new drug is not high The specific content of the announcement to increase the number of cases can be seen, while Annex III of the measures for the administration of drug registration stipulates that the number of phase III clinical cases shall not be less than 300 Why increase the number of cases? What the company said is not very clear, just saying that it does not meet the relevant requirements without increase Is the case shedding rate higher than 20%? And it is reasonable to say that if there is a problem in other aspects, additional test funds should not be increased step by step Generally speaking, it's a normal process, maybe temporarily adding an indication Generally speaking, there are different opinions on both sides, and they are all right As for the specific stock situation, it depends on which side has more supporters Once the subsequent event is unveiled, it will be true Penicillin statement: This article is an integrated article, and the viewpoint only represents the author, not the position of yaozhi.com If the content, copyright and other issues are involved, please contact the message on this website, and we will delete the content as soon as possible.