Investor NDA Update
Navidea Provides Lymphoseek® NDA Update Statement
October 10, 2012
On September 24, 2012, Navidea issued a statement that, as part of its continuing effort to secure regulatory NDA approval for Lymphoseek® (technetium Tc 99m tilmanocept) Injection, a Type A meeting with the FDA had been scheduled to advance the Company's planned response to the Agency regarding deficiencies in current Good Manufacturing Practice (cGMP) identified during inspections at third-party manufacturing facilities.
The Company has now successfully completed the Type A meeting with the FDA and has received clarifying guidance from the Agency in regard to the cGMP issues noted in the FDA's Complete Response Letter (CRL) received on September 10, 2012 and the requirements for the Company's response to the CRL for the Lymphoseek NDA.
The meeting confirmed that the scope of the Navidea resubmission will be focused on the previously noted cGMP manufacturing deficiencies observed at third-party manufacturing facilities. The meeting further affirmed the requirements that the Company must address in its resubmission.
The Company continues to believe this process will not entail a re-review of the full NDA. The Company also believes that a majority of the requirements needed from the third-party manufacturing facilities to address the noted deficiencies have already been completed.
Navidea anticipates providing further information regarding the timing for resubmission and related matters by early November. Gaining approval for Lymphoseek continues to be the priority of the Company as we continue to develop our pipeline and advance Navidea's position as a leading precision diagnostics company.
"The Company continues to believe this process will not entail a re-review of the full NDA."
This sentence sounds awful washy. They couldn't get clarity on whether or not there would be a re-review of the full NDA during their meeting with the FDA?
I doubt the FDA would give them any guarantees, so it wouldn't be smart for them to say there isn't going to be a complete review. Don't forget there are already some lawyers looking to file suit for NAVB supposedly being too optimistic.
I think they just say "believe" as a CYA. According to press release on day of CRL, only the issues in the CRL will need re-reviewed, everything else was fine - just the third party manufacturing issues.
Really strange that the price per share hasn't spiked up on this news.
The MM's certainly have a close reign on this stock. IMO, won't be long before they won't be able to keep it down.
Sentiment: Strong Buy
"Navidea anticipates providing further information regarding the timing for resubmission and related matters by early November"
I guess we'll see what the market thinks of that - so far a neutral response. What do you guys/gals think? Were you expecting something sooner? Like the market, I'm neutral.
Well, I didn't think the meeting would be until next week. At least it is now over - now they can address the re-submission process. Back to a waiting game. Would be nice if they end up re-submitting on Nov. 1st rather than just giving an update early November - that would be a nice surprise. Oh well - I am underwater and a bagholder for now . . .
The Company also believes that a majority of the requirements needed from the third-party manufacturing facilities to address the noted deficiencies have already been completed.
I expected a spike. its a bad day perhaps there needs to be some digestion