$Novavax (NVAX.US)$ Asking for more information is a normal ...
$Novavax(NVAX.US$ Asking for more information is a normal part of the regulatory process. It is not a setback. In addition, India said that it would not approve a non-Indian vaccine unless one of the 2 Following items occur:
A domestic phase 3 trial was done and completed in India. Or one of the following five drug agencies approve it: the UK, the EU, the US, Japan or the WHO.
Since neither of the two things above have occurred yet, the Indian drug agency would not be ready to approve it now anyway. So asking for information is not a delay.
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ceerup : Boy, that's a relief. I thought something was bad.
LITWENe ceerup: That’s a good one.
madman123 : 1) No Phase 3 trial was done in India other than that for children
2) The 5 countries / organizations mentioned have much higher standards. That's why getting approval from them is not that easy. And Novavax just straight out did not submit for US FDA because they tried once and know that they won't meet the standards.
ETFWorldSavior : This is exactly on point. Trial in India is ongoing. Of course they back and forth with “asked” for information. These hit pieces keep coming characterizing nothingness as “another delay”. That being said, hit piece was published day before… I don’t think it caused the fall.
darthzazu ETFWorldSavior: Yup, it's sometimes hard to say what's causing sizable single-day jumps and pullbacks because there are so many technical traders, day traders and momentum traders who are involved with this stock during the last half year. They are basically a herd, and when some of them start moving in one direction, the herd goes that way too. Then stop loss sell orders are triggered, which increases the selling pressure, and likewise some margin calls take place, and that creates more selling. And so forth. Hard to tell if that's what occurred today or not.
Buvirus Upanishad darthzazu: You have to ask then why SII filed for authorization without meeting either of those two criteria? They are running the trial and submitted interim data along with the request. Are they that naive to think DCGI would approve based on interim data? No, they most likely expected authorization from one of the major countries would have already occurred by the time their filing was reviewed. That strategy backfired when DCGI said bring me another rock while we wait for UK or EU to authorize, giving traders the opportunity to do what they did yesterday.