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	<title> &#187; Boceprevir Schering Plough Hep C Phase II Phase III Ver</title>
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		<title> &#187; Boceprevir Schering Plough Hep C Phase II Phase III Ver</title>
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		<title>Some More Detail on the &#8220;Horse Race&#8221; to Phase III for Next-Gen Hep C Drug candidates. . . .</title>
		<link>http://shearlingsplowed.wordpress.com/2008/06/24/some-more-detail-on-the-horse-race-to-phase-iii-for-next-gen-hep-c-drug-candidates/</link>
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		<pubDate>Tue, 24 Jun 2008 15:41:48 +0000</pubDate>
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		<category><![CDATA[Boceprevir Schering Plough Hep C Phase II Phase III Ver]]></category>

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		<description><![CDATA[[UPDATED 11:00 AM EDT -- Adam Feurstein at The Street has gotten this story exactly backwards. Exactly. That is my view; that is also the view of several of the more-learned Wall  Street analysts, as well (from Feurstein's piece, at the end):
". . . .Cowen &#38; Co. analyst Rachel McMinn views Monday's [Vertex] selloff [...]<img alt="" border="0" src="http://stats.wordpress.com/b.gif?host=shearlingsplowed.wordpress.com&blog=3697016&post=527&subd=shearlingsplowed&ref=&feed=1" />]]></description>
			<content:encoded><![CDATA[<div class='snap_preview'><br /><p><BR>[<strong>UPDATED 11:00 AM EDT </strong>-- Adam Feurstein at <a href="http://www.thestreet.com/_yahoo/newsanalysis/biotech/10422784.html?cm_ven=YAHOO&amp;cm_cat=FREE&amp;cm_ite=NA">The Street has gotten this story exactly backwards</a>. Exactly. That is my view; that is also the view of several of the more-learned Wall <a href="http://bp1.blogger.com/_M_OtwEgZgAk/SE1YCBTmbZI/AAAAAAAABe4/Dsw9t7rW3Uo/s1600-h/SGP-Vertex.jpg"><img style="float:right;cursor:hand;margin:0 0 10px 10px;" src="http://bp1.blogger.com/_M_OtwEgZgAk/SE1YCBTmbZI/AAAAAAAABe4/Dsw9t7rW3Uo/s320/SGP-Vertex.jpg" border="0" /></a> Street analysts, as well (from Feurstein's piece, at the end):<br />
<font color="#040080">"<i>. . . .Cowen &amp; Co. analyst Rachel McMinn views Monday's [Vertex] selloff as an overreaction to expected news. She reiterated her <strong>outperform</strong> raring [sic] on Vertex.</p>
<blockquote><p>&#8220;We believe that yesterday&#8217;s [Vertex] sell off was driven by an over-reaction to two-week old information. Timelines for commercial launch of. . . . telaprevir (late 2010/early 2010) are unchanged, and we see 50% upside relative to the market on the basis of this timeframe. While probability of an early 2009 FDA approval is low, we see 100% upside relative to the market under this scenario over the next 6-12 months. . . .&#8221;</i></p></blockquote>
<p></font><br />
~~~~~~~~~~~</p>
<p>Some mindless stock-boosters, over at Yahoo!, set me to digging more deeply (background, from my earlier <a href="http://shearlingsplowed.blogspot.com/2008/06/schering-plough-competitor-takes-leap.html">post on Vertex</a>&#8217;s candidate, here) into what Schering has <em><strong>actually disclosed </strong></em>about its next  generation Hep C Drug candidate &#8212; and, what I found is actually rather comical:</p>
<blockquote><p><font color="DARKGREEN">&#8220;<i>. . . .A phase III protocol has been submitted to the FDA and <strong>the company is waiting for concurrence from the FDA </strong>prior to beginning phase III clinical trials. . . . Schering-Plough is also <strong>working through the complex chemical synthetic p</strong>rocess to <strong>build</strong> additional qualified <strong>clinical supplies </strong>for the phase III clinical trials. . . .</i>&#8220;</font></p></blockquote>
<p>That was from Schering-Plough&#8217;s <A href="http://media.corporate-ir.net/media_files/irol/89/89839/FAQ_042108_Final.pdf">April 21, 2008 Investor FAQs</a> (from the bottom of page 1, to top of page 2, of the PDF file).</p>
<p>Next, in June 2008 (no exact date available), Schering <em><strong>updated</strong></em> its &#8220;<em>Product Pipeline Chart</em>&#8221; (PDF file), adding this text:</p>
<blockquote><p><font color="#040080"><br />
&#8220;. . . .<i><strong>Phase II</strong></p>
<p>. . . .<strong>Boceprevir</strong></p>
<p>In May 2008, Schering-Plough announced that it is initiating two Phase III studies with boceprevir in patients chronically infected with hepatitis C virus (HCV) genotype 1. <strong>The compound will remain in Phase II until patient dosing commences </strong>in the Phase III trial. . . .</i>&#8220;</font></p></blockquote>
<p>That quote comes from <a href="http://media.corporate-ir.net/media_files/IROL/89/89839/S-P_Pipeline_June_2008_Final2.pdf">the top of page 2, first column of text</a>, of the &#8220;Pipeline&#8221; PDF file.</p>
<p>Read together, it is very-likely that FDA has <em>not yet signed off</em> on the SGP Phase III study design. I mean, seriously &#8212; if FDA had cleared Schering&#8217;s Phase III study designs, wouldn&#8217;t Schering have very-directly said so?</p>
<p>Perhaps more importantly, it is <strong><em>also increasingly clear </em></strong>that Schering-Plough is having some difficulty (as a matter of physical chemistry) manufacturing adequate supplies of tits drug candidate to even <em><strong>begin dosing </strong></em>the Phase III patients &#8212; re-read this, from April 2008: <font color="DARKGREEN">&#8220;<i>. . .working through the complex chemical synthetic process to <strong>build additional qualified clinical supplies </strong>for the phase III clinical trials. . .</i>&#8220;</font></p>
<p>And, that line would actually dove-tail with the odd &#8220;<em>asterisked</em>&#8221; disclosure on page 1 of the <A href="http://media.corporate-ir.net/media_files/IROL/89/89839/S-P_Pipeline_June_2008_Final2.pdf">June 2008 &#8220;Pipeline&#8221; sheet</a> &#8212; about staying in <em><strong>Phase II</strong></em>, until &#8220;<em>dosing commences</em>&#8221; for the Phase III group.</p>
<p>It is almost humorous: the oft&#8217; befuddling-fog &#8212; over at Schering Plough Resaerch Institute &#8212; of only-positive-information. . . . magically becomes as clear as a crisp mountain morning, if one reads about, <em>around</em>, over and <em>through</em> its myriad, disparate disclosures on any given topic. . . . long enough, hard enough and with a truly independent eye.</p>
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