Form F-1/A Link: https://t.co/RQcYLFMXQO
Okay hope everyone having a lovely weekend. Lots of love today. Feeling very blessed 🥰 Going through NNOX tweets from last week. Time to compile threads and bring you highlights. No need to go digging old tweets if I do for you 🤗 FDA, Secondary, and 3P510k. Let’s review..
Form F-1/A Link: https://t.co/RQcYLFMXQO
Reference to Eagle eyes: https://t.co/gT779MFX82
We discover in F-1 that 3P510K recommended clearance of Nanox Source. This triggers a 30 day timeline to approval by FDA. However ...
Eagle-eyes \U0001f985 https://t.co/w1wF3Ysmt1
— Harvey \U0001f1fa\U0001f1f8 (@realharveymark) February 12, 2021
The short thesis destroyed by the recommend clearance. Go back see where NNOX trade before short report. You will recognize the number. Okay you see the number approx the analyst price targets and secondary pricing.
NNOX here\u2019s a link about FDA Third Party Review Program. https://t.co/hlrrlXi6Us
— Harvey \U0001f1fa\U0001f1f8 (@realharveymark) February 11, 2021
"The FDA's review timeframe for a MDUFA decision is within 30 days after receiving the recommendation of a 3P510k Review Organization."
I typo 99 mean pg 97 but this covered in F-1. Nanox has mapped this out fully and tell you exactly what to expect.
These are two important NNOX points. 3P510K 30 day, FDA classification decision covered for you
The \u201cde novo\u201d process is a risk-based classification determination means low to moderate risk novel medical devices can have route to market. Okay this is contingency talk. This is a short seller dream scenario. FUD gonna get all over everything but not you. You go to F-1/A pg 99
— Harvey \U0001f1fa\U0001f1f8 (@realharveymark) February 11, 2021
Tomorrow FDA will publish all approvals that occur last week. It very possible NNOX is there. Maybe 60% chance
30 days \U0001f60e https://t.co/Qj80xn00pI
— Harvey \U0001f1fa\U0001f1f8 (@realharveymark) February 12, 2021
More from Life
"I lied about my basic beliefs in order to keep a prestigious job. Now that it will be zero-cost to me, I have a few things to say."
We know that elite institutions like the one Flier was in (partial) charge of rely on irrelevant status markers like private school education, whiteness, legacy, and ability to charm an old white guy at an interview.
Harvard's discriminatory policies are becoming increasingly well known, across the political spectrum (see, e.g., the recent lawsuit on discrimination against East Asian applications.)
It's refreshing to hear a senior administrator admits to personally opposing policies that attempt to remedy these basic flaws. These are flaws that harm his institution's ability to do cutting-edge research and to serve the public.
Harvard is being eclipsed by institutions that have different ideas about how to run a 21st Century institution. Stanford, for one; the UC system; the "public Ivys".
As a dean of a major academic institution, I could not have said this. But I will now. Requiring such statements in applications for appointments and promotions is an affront to academic freedom, and diminishes the true value of diversity, equity of inclusion by trivializing it. https://t.co/NfcI5VLODi
— Jeffrey Flier (@jflier) November 10, 2018
We know that elite institutions like the one Flier was in (partial) charge of rely on irrelevant status markers like private school education, whiteness, legacy, and ability to charm an old white guy at an interview.
Harvard's discriminatory policies are becoming increasingly well known, across the political spectrum (see, e.g., the recent lawsuit on discrimination against East Asian applications.)
It's refreshing to hear a senior administrator admits to personally opposing policies that attempt to remedy these basic flaws. These are flaws that harm his institution's ability to do cutting-edge research and to serve the public.
Harvard is being eclipsed by institutions that have different ideas about how to run a 21st Century institution. Stanford, for one; the UC system; the "public Ivys".
