marathon...............that number is a direct quote from FDA. So far they are the only #s I have found. If you can find more relevant or correct data that would be great. I agree the #s and %s are not very clear. As to just Fast Track %s. To me the statement from the FDA quote is not clear as it states " Fast Track, Breakthrough, or both."
Go to NVAX web site, read news releases for 2014 there you will find info. about primates and maternal placental transfer of antibodys.
You must be short or working for tutes trying to lower pps.
From FDA Dot Gov.
"Fast Track and Breakthrough Therapy designations are designed to speed the development of promising new drugs intended to treat serious conditions with unmet medical needs. Almost half – 19 or 46% of the 41 novel new drugs approved in 2014 — were designated as Fast Track, Breakthrough, or both."
I would give it a 50 / 50. When full data set is released for p2, I suspect the approval probability or odds to increase.
From FDA web site they have approved a higher percentages in 2014 than past years. The tutes know this and they want all retail shares.
Nov 20, 2014
U.S. FDA Grants Fast Track Designation to Novavax' RSV F-Protein Nanoparticle Vaccine for Protection of Infants Via Maternal Immunization -
Now ask yourself would the FDA Grant Fast Track if they (FDA) didn't see positive data.
Oct 29, 2014
U.S. FDA Grants Fast Track Designation to Novavax' H7N9 Influenza Virus-Like Particle Vaccine Candidate Adjuvanted With Matrix-M(TM) -
Sep 08, 2014
ICAAC Presentation: Immunization of Pregnant Baboons With the RSV F Nanoparticle Vaccine Protects Infant Baboons Challenged With Respiratory Syncytial Virus in a Comparable Manner to Infants Prophylaxed With Palivizumab -
It is all there on NVAX website 2014 news, when in doubt go back and read. I think posters have been planted on NVAX msg. board to create doubt and scare retail out of their shares.
To the short term flippers just say NO remove your stop / loss orders stop the day trading and watch the pps rise. When there are no more shares to steal they buyer will be forced to bid the pps up. I have been adding on these pullbacks on low volume. For each dollar they pull it back I add.
cosaman that is also the way I understand it. I am confident there are others here more knowledgeable in the field than I. Perhaps they will share their knowledge.
stock........I have not seen any data from NVAX regarding animal studies involving VLP-RSV antibody placental transfer. If others have please give a link. However I would have to think NVAX has completed some in vitro or animal studies, otherwise no reasoning for expensive trials, on a total unknown. Therefore I must assume such studies have been completed, with positive results. There have been human and animal studies with other VLP's, that produced positive results.
There is data that supports maternal vaccinations for Pertussisl which is a highly contagious respiratory disease. The data supports the transfer of antibodies from mother to the unborn infant.
However we must remember Pertussis is a bacteria (organism) induced respiratory disease, where as RSV is a virus (via RNA) induced respiratory disease, different mechanisms. So it is not a direct apples to apples comparision. There have been other maternal studies that show promise for viral diseases and the placental transfer of antibodies.
I am not a virologists, bacterologists or immunologists, so my words may not be 100% correct.
NVAX needs to give up some more data which may happen very soon. There is a reason so many tutes have so many shares and somebody keeps walking the pps down on low volume. If this were a high volume sell-off I would be more concerned. Somebody wants the retailers shares.
It has been many years since I have seen so many 0's on a P&F Chart and that was well before all of the good news so far this year.
Large % of shares of NVAX are in Tutes hands and they control the trading, us little peons have no influence.
I think they are washing out all weak hands that are here for quick flip trading, or chasing a up run. Also I think there is a New Tute buyer in the low 10's with an order in, in anticipation of what will come later this month and this quarter. They can't buy all at once it would rock the stock too Hi too fast and we loose stability, as we have just seen. Consolidation zones is when serious long term buyers buy, or on support levels, which appears to be in the low 10s. They never show their hands, they prefer to buy undercover and unnoticed. Glad too see some consolidation even though it is wide swings 10s to 11.5s, which brings the swing traders in. I think they are now soaking up the swing traders shares. And soon those shares will be gone and in stronger hands, lookin for another low wick as final wash. Watchin wicks and volume. This may last till after FED Meets. But me nibbling low 10s.
And that is just what the Big money wants. They are using the FED, China and various indexes as an excuse to shake NVAX up. Nothing wrong with taking a bit of a profit and buying back at a lower cost. If you get the lower cost. But hey free........when I read your posts you are just a trader anyways. I see you sometimes write about buying and selling in the same day. These days have been low volume sell-offs when compared to the big volume up day. I am sure they gladly took those shares off your hands.
3 Times now, every time NVAX approaches 10 it moves up quickly with strong volume. Take note of the 3
candles with lower wicks. Big money is supporting 10 and using every opportunity to buy. Shakin out the shakey. Or could be shorts snapping up shares to cover. Either way big buyers around 10. Each time it is a little higher 10.03........10.05....then 10.08. What will be the next number??????????