PropThink: NAVB Re-Submits Lymphoseek NDA; Approval Could Come Soon
(Thomson Reuters ONE) -
By David Moskowitz
Navidea Biopharmaceuticals (NASDAQ:NAVB) announced that on October 30th it
resubmitted its new drug application (NDA) for Lymphoseek in response to the
FDA's Complete Response Letter (CRL), which was issued on September 10th. (see
PropThink's prior story). In just over 1.5 months, the company has met with the
FDA, clarified the issues in the CRL required for NDA submission, resolved the
issues, and executed on re-filing the application, supporting management's
claims that the manufacturing questions were minor and expected to be addressed
soon. The turn-around by the FDA could be rapid, as the company believes that
just the portion of the NDA concerning third-party manufacturing questions will
need to be reviewed before a decision is made. The incentive for the agency to
make Lymphoseek available is that this diagnostic has significant advantages
over currently used colloid-based imaging agents. Advantages include high
resolution mapping of cancer in the lymph nodes, lower side effects, and more
convenient administration. The advantages of Lymphoseek enable physicians to
"stage" patients with metastatic breast cancer more appropriately, which
generally leads to better treatment outcomes.
Assuming Lymphoseek is approved in the next couple of months, the company has
stated that NAVB and its U.S. commercial partner, Cardinal Health (NYSE:CAH),
are prepared to launch the diagnostic shortly thereafter. In a press release
Wednesday, NAVB also noted that it continues to advance efforts to market
Lymphoseek globally by filing for regulatory approval in the EU and furthering
discussions with potential ex-U.S. commercial partners. Analyst price targets
range from $5.75 to $7.50 for NAVB following the Lymphoseek setback in
September, but a swift resolution could result in those price targets going
higher. Ladenburg Thalmann estimates peak Lymphoseek sales of around $450M, so
assuming FDA completes its review of the NDA rapidly, and the product receives
marketing approval, NAVB could break through its highs seen earlier this year.
Click here to see this article in its original form.
About PropThink
PropThink is an intelligence service that delivers long and short trading ideas
to investors in the healthcare and life sciences sectors. Our focus is on
identifying and analyzing technically-complicated companies and equities that
are grossly over or under-valued. We offer daily market coverage, weekly feature
stories, and a newsletter to investors who subscribe on PropThink.com. To learn
more, follow us on Twitter or visit us at http://www.propthink.com.
Disclaimer:
You should assume that as of the publication date of any report or letter,
PropThink, LLC and persons or entities with whom it has relation ships
(collectively referred to as "PropThink") has a position in all stocks (and/or
options of the stock) covered herein that is consistent with the position set
forth in our research report. Following publication of any report or
letter, PropThink intends to continue transacting in the securities covered
herein, and we may be long, short, or neutral at any time hereafter regardless
of our initial recommendation. To the best of our knowledge and belief, all
information contained herein is accurate and reliable, and has been obtained
from public sources we believe to be accurate and reliable, and not from company
insiders or persons who have a relationship with company insiders. PropThink was
not compensated to publish this article. Our full disclaimer is available
at http://www.propthink.com/disclaimer.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: PropThink via Thomson Reuters ONE
[HUG#1654152]
Unternehmensinformation / Kurzprofil:
Datum: 31.10.2012 - 16:26 Uhr
Sprache: Deutsch
News-ID 198248
Anzahl Zeichen: 4478
contact information:
Town:
New York
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 246 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"PropThink: NAVB Re-Submits Lymphoseek NDA; Approval Could Come Soon"
steht unter der journalistisch-redaktionellen Verantwortung von
PropThink (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
