dont forget on top of bamboo new plant start production with target rmb200mil per annum. rmb600mil for 3 years under phase one. Hotel rental collection worth rm11 mil per annum. like this add more glove revenue if Q1 really start production as plan. Kanger will be able to turn around lah. If lah. all are according to schedule plan lah. correct?
director also like you lah. shareholder. which shareholder dont see money is important one. cannot blame him lah. he is just like many of you here lah. correct?
now important is dont talk about vaccine again lah. Vaccine ctrs cirit birit. no benefit to talk about it lah. it will make more investor to sell lah. correct?
1)How long it need to register a product in Malaysia ya?
2)To register, do you need Malaysia clinical data ya? If need, how long a clinical trial will take ?
Health DG already announced :-
-The vaccine is an inactivated virus vaccine that is developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) in Beijing (China). -on Dec 10, the Medical Research Ethical Committee (MREC) will look into the law and research ethics. Once approved, we can probably start the study by end of this month or next year,”
1) Depends which registration pathway. I will not go into the details of the differences and the various conditions for eligibility of the various pathways as it is complicated and long winded to explain here. There are several types of registration pathways as follows :
(a) Normal registration pathway will take not more than 245 working days for biologics product category (including vaccines)
(b) Priority review registration pathway will take not more than 120 working days for biologics product category (including vaccines)
(c) Facilitated registration pathway : (i) Not more than 120 working days for abbreviated review for biologics product category (including vaccines)
(ii) Not more than 90 working days for verification review for biologics product category (including vaccines)
(d) Fast track conditonal registration pathway (This is a new pathway that was very recently introduced specifically to cater for pandemic situation) : Not more than 60 working days for biologics product category (including vaccines)
NOTE :
For (a), (b) and (c), either full registration may be given (5 years validity will be granted before renewal of registration provided complete clinical data) or conditional registration may be given (2 years validity only if clinical data provided is until phase 2 or until interim phase 3. Full clinical data must be provided prior to renewal of registration in order to be eligible for full 5 years validity)
For (d), only conditional registration with 1 year validity will be granted. The complete clinical data should be provided before renewal of registration upon which full 5 year validity should be granted.
2) I will not answer this question again which you have already asked me earlier today and i have given you the answer. If you do not believe what i explained to you earlier, then i cannot help you.
I was given to understand that it is not as fast as you portrayed. Even friend in pharma industry said registration of usual medicine will take at least 12 to 18 months. Vaccine so fast?
anyway I am not expert in the industry, not going to argue with you.
See, if u look deeper to the kanger core biz how big the potential that company can generate, vaccine is juz a bonus, smile. But we need a little bit time to translate to the share price. By looking into that, yr investment is safe and highly chances to grow up soon. Esok kasi up, smile
@BALANCE_VIEW Depends which category of drug. For new chemical entity and Biologics cateogry(including vaccines),despite a longer timeline allocated in the registration guidelines compared to say generic drug category (only 210 working days), in reality the evaluation timeline taken is usually faster for new chemical entity and biologic products (including vaccines) due to lesser backlog of submissions as well as higher percentage of products from new chemical entity and biologics product category are eligible and submitted via the priority review and facilitated registration pathway which has a shorter timeline as i have highlighted above. In reality due to insufficient number staff, the allocated timeline as stated in the registration guidelines may not achieved occasionally due to large backlog of submissions. I hope this answers your confusion on this matter.
@NPRA1985 cool. Had some interaction with NPRA (or should I say NPCB) a few years ago. CINP unit was quite efficient, and I believe if there is an urgent agenda like the current pandemic, review of the CTIL/CTX shouldn't take so long? Any reasonable guesstimate?
@tradesafely Firstly, it is important to note that currently, local clinical studies are not required for registration of drug products or vaccines in Malaysia and NPRA will accept foreign clinical trial data during the registration process.
I do know something about the timeline even though i do not work at CINP unit. NPRA recently published a circular sometime this year announcing the fast-track review of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) applications with a shorter review timeline whereby the date of implementation of the circular was effective from 1 April 2020 onwards.
The criteria for fast-track review include the application of new research products used for treatment/prevention in pandemic/epidemic situations for public health except for the First-in-Human (FIH) study. You can refer the link below for further information.
Of late there are so many new comers to this Kanger forum asking so many questions. You all would realise we do not ask people to buy, sell or cut loss. We just state facts and if at all provide links for all to read up. This is what and who Kanger supporters are.
Or shall we refrain from posting facts and go into speculative mode? Up ah, Huat ah, Buy now if not regret, Something big is coming, wait for announcement....(Goreng, Goreng ...I am just joking, okie)
Happy trading..hopefully prices go up today, seriously. :)
This book is the result of the author's many years of experience and observation throughout his 26 years in the stockbroking industry. It was written for general public to learn to invest based on facts and not on fantasies or hearsay....
UlarSawa
35,552 posts
Posted by UlarSawa > 2020-12-08 22:09 | Report Abuse
mr wu is opportunist. money face. you see his forehead got dollar sign. correct?