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RobotDroid

01/28/19 1:13 PM

#17951 RE: staticmirror79 #17950

AF is a hack with zero biotech experience or knowledge. He sure left out a lot in that OPINION/RANT, and he has been 100% wrong on other trials (Mankind anyone). Take his opinion with a grain of salt and a shot of tequila, he is clueless, post hyperbole and guesses, and has a terrible track record.
From himself, with the first papragraph basically about nothing he calls a win...
"Accountability time. Here's my 2016 report card.

Last January, I made a single, overarching prediction about biotech stocks for 2016:

2016 will be a difficult year for biotech stocks... The five-year party which saw biotech stocks outperform the broader markets comes to an end in 2016. Good biotech science marches on, but negative fund flows, a continued flurry of negative headlines about drug prices and the presidential election all contribute to lousy stock performance overall.

I'll place that one in the win column.

Sarepta Therapeutics (SRPT - Get Report) was one of the most dramatic and volatile biotech story lines in 2016. My track record was mixed. I had the correct read of Janet Woodcock's "approve Exondys" mindset coming out of what looked, on the surface, like a negative FDA advisory committee meeting. Exondys was approved.

I was also too dismissive of the disagreements within the FDA caused by Woodcock's decision to approve Exondys. I did not anticipate the pushback by insurance companies over reimbursement, which slowed the drug's commercial launch. Sarepta's stock price trades as if Exondys was not approved, and that's not the year-end outcome that bulls (myself included) thought would happen."
Once a loser, always a loser...
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The_Q

01/28/19 1:50 PM

#17952 RE: staticmirror79 #17950

The dispute is real simple

1. The FDA did eventually know
2. The FDA withdrew the hold because they knew of potential benefit
3. 2014 and 2016 had no way of discerning conclusive benefit because data wasn't observed yet with enough deaths
4. Enough deaths came to warrant FDA removal of clinical hold, or how else would they see benefit.
5. Most importantly, the IDMC gave NO DIRECT MENTION of ANY PROBLEM TOWARD MK, PERIOD.
6. The IMDC was solely worried about delaying standard protocol for 21 days for an unknown benefit

If CVM solely wanted to delay bad news, they'll be sued up the ass for all the returns to be refunded.... Unless Geert et al want to move to zimbabwe to shelter their 200K they made off of a failure, it seems pretty insane to assume this is their purpose
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sushifishman

01/28/19 1:52 PM

#17953 RE: staticmirror79 #17950

Anthony had this to say about Fearstein from the Yahoo Mssg board

"Feurstein is wrong!! Here is why: The FDA, as required by law reviewed the study and then released the hold with NO changes to protocol ! The company , by law, can not release the details. They had to find a "likelihood" of approval to release the hold. Also, the IDMC in December 2017 and August 2018 said to continue with no changes."