I would be disappointed if it takes until Christmas. By CFDA's chart time-line it should now be within any day! Having said that, nothing has went fast with this one. I waited this long so another month or so won't matter.
Am I calculating wrong or could this one vaccine along with regular vaccine growth make the company worth about 5 times what they are worth now with-in a year? IMO, Luck, Life
The one main thing they announced is that the Clinical samples for EV-71 passed the required testing. Also the EV-71 factory passed the GMP inspection. The CFDA website says NDA should follow with-in 30 days after GMP cert, and approved vaccine samples. They also said they had enough money for the next year.
Question is does SVA have the actual certificates yet for the samples and the GMP? They are always so ambiguous it is hard to get any real timeline. IMO, Luck Life
China's new two child policy will play out into a vast new increase of infant vaccines for the millions upon millions of expected new babies. Sinovac is well positioned for the growth!
In addition the dipping interest rates in China will make it easier to get any money needed for expansion without destroying shareholder value. IMO, luck, Life
Surf had a question in the last post about what was happening in respect to Sinovac and the Gate's foundation if any? Well, you have do keep up on things to see it, but maybe this will help you.
Intravacc of the Netherlands signed a technology transfer agreement in April of 2014 with Sinovac to make and produce a Sabin Polio inactivated Vaccine in China and commercialize that vaccine. I assume for not only China but other developing countries needing the vaccine. In that agreement Sinovac has apparently guaranteed to make a minimum of 20 million doses of this vaccine per year for that use with the help of Intravacc.
The Global Polio Eradication Initiative or the GPEI as it is known helps to finance Intravacc's Polio vaccine development and to find suitable partners for it's manufacture and distribution. The WHO, the Gates foundation and many others are among many others making up the GPEI.
Do some studying on Intravacc and the GPEI and I think you will be enlightened and be very pleased that Sinovac is working on that much needed vaccine! IMO, Luck Life.
In addition to SVA, ( Sinovac Biotech) already having approval for Clinical trials on PPV, PCV and Varicella ,they have also successfully completed Clinical trials on EV-71 for HFMD and are waiting on the NDA for EV-71.
They also have 6 or seven vaccines already on their local market and International market. IMO, Luck, Life
Recently, First Manhattan Co. seems to have taken a new position in Sinovac of 603,666 shares. Their Bio says they invest Warren Buffett Style and most of their customers own some Berkshire stock also.
Warren Buffett and Bill Gates visited Sinovac in September, 2010 on a Joint trip to China. It was the first company visited there. Just some interesting tidbits! IMO, Luck, Life
Emarbach, Thanks for making the effort to get such an in-depth interview with SVA. It definitely reinforces my reasons to hold their company stock.
The only thing I could see wrong with SVA's responses were they seemed to wander off point. Example, rehashing phase I, 3 of EV-71 and building the EV-71 plant leading a reader to think all that still had to be done!
SVA said in their interview that most of their shareholders already know what's going on because they have been with them for a long time. (Exactly! ) In my opinion, that is a main reason why there is a lack of new shareholder interest! I don't think most retail shareholders have a clue to the potential! SVA's P.R.s always seem to be written for current shareholders, not prospective ones. To their defense, they are living in China and the rules are vastly different from the U.S.
Everything I read says they should be down to less then two months for an NDA for EV-71, but I understand fully why they can't say that and are cautious. Again, great interview, thanks! IMO, Luck, life
Sorry I missed the chance, I was not checking the website for the past few days due to being extremely busy. Thanks for being there, I'll look forward to reading you blog IMO, Luck, Life
In this mornings news! Sinovac is once again part of China's seasonal flu vaccination program and are starting to ship in the third quarter 2015 which is now! IMO, Luck, Life
My personal clarity comes from the chart on SVA's website under events and presentations showing the CFDA's timelines. I'm certain that we at about 2 to 3 months or less until approval. This would put the timeline at the very longest it would take to get a new drug approved in China through the new system.. Since it is a world first new drug, that long period seems to be normal, however in the future I would expect the PPV drug to go through somewhat faster not being a Novel vaccine.
It certainly has been a long road for shareholders! Mr. Yin said in the last C.C. 4 months to commercialize after the NDA. I would think they would start lining up orders ahead of finished production, either way it would be on the market for both 2016 HFMD seasons. Being that Mr. Stock Market always looks ahead, I think we should see a steadily improving upward trend.
Keep up your good work emarbach, your posts are much valued ! IMO, Luck, Life
I'm looking for $15.00 once people realize the extent this will change the companies revenues not to mention SVA is looking to go international with most if not all of their current drugs including EV-71.
It sounds like SVA has two separate factories ready to produce the vaccine per S.A. IMO, Luck, Life
On the seeking alpha's website, they have a free article written in May of 2015 that tells a lot of what's going on with SVA. It was written right before 1st quarter earnings came out and as we know first quarter was weak.
However, second quarter was very strong and the article is even more on target now. It talks about the potential demand for EV-71 when approved, and puts an estimated dollar value on how much of the pie the company might get. If you are confused about SVA, you need to read the article as it is right on target! Also EV-71 is only one of many things they have going on.
IMO, Luck, Life