SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : CEPH
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: IN_GOD_I_TRUST who wrote (180)5/8/1997 11:26:00 PM
From: WeirdPro Randy   of 998
 
Today's split decision has an excellent chance to be reversed.
The following from a very knowlegeable person posting on the motley fool board:

<<I was at the FDA Panel Meeting today.
I think the FDA got what they wanted from this Panel.
It seems the MDs on the panel (especially the chair - Sid Gilman) equate the lack of a statistically significant European study with proof that the drug "did not work in this study". Nothing could be further from the truth since the lack of statistical significance simply means it cannot be shown with certainty that the drug did work. Get the difference that was lost on the docs? Some of my observations are:
1)The docs have NO understanding of basic biostatistics
2)I don't think any of the physicians on the Panel treat ALS patients - this all seemed new to them
3)The docs are convinced that the US study was "weak and of marginal significance". This in spite of a series of the leading US ALS physician investigators testifying that the US study was the most robust study they had seen among the ~40 studies conducted during the past 20 years.
4)The safety of Myotrophin was not in doubt
5)Patients and ALS treating physicians pleaded with the panel to allow them the choice of whether to use this agent or not. "What harm would it do to approve ...?"
6)The docs on the Panel actually were expecting that CEPH would have completed a new study during the past 9 months and presented data at this meeting. HELLO ?

My sense was that the FDA will still approve this drug soon. If they don't, I think a lot of ALS patients will lose their supply of Myotrophin...>>
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News