Quote from Spokane paper, Spokesman-Review, from last year - "The FDA action (warning letter), however, does halt Hollister-Stier's production of substances being developed for clinical trials before they can receive final federal approval. Such substances are referred to as new drug applications, or NDA contracts."
"HS can't resume its NDA contracts until the FDA lifts the sanction. What's more, the FDA noted that 'other federal agencies may take this warning letter into account when considering the award of contracts'".
In my limited view, given the amount of time that the warning letter has had to be lifted, this is too close to the PDUFA date to be taking chances. HS has had over a year to correct this. I would watch the situation very carefully.
Delay is pretty much expected. How do I know that? Two factors.
Everyone knows the situation and that Jubilant is the key. In fact, the stock may move more on positive Jubilant news than the actual FDA decision.
Second is the lack of paid hecklers / spammers on this board. With one week to go, 8 out of 10 posts should be negative.
Sentiment: Strong Buy
Jackie_iitt . *** are you jock_hemmer_flea . Brother in law or life partner . ) o ( . I knew you have the money . You facking three dollar bills . Out side lady in side man . This message from . Bcrx long share owners .
yeah, thx. my kids say that line from Monsters Inc. and it had to come out of my head.
Point of the post is Jubilant would likely make a PR about the Spokane facility as soon as FDA clears it. Rapivab is joined at the hip for the CMC to have clearance before approval.
Let's hope we hear about this within days.
Posted by a Jubilant Life Science investor today regarding Jubilant stock:
Dec. 16, 2014
Buy now. US Spokane facility news will come any time. USFDA tightening Chinese company may get you winfall benefit from here. Read ET news page 6 dt 16 dec.
Always watching, always watching
$12-13 before PDUFA, $9-18 after ($18 if Rapivab approved); $20-$30 if NHP and Phase I 4430 positive. Remember Jan 15 is date for response to pandemic MCM RFP's, and the turkeys are chickens are dying just across the border in Canada.
December 16, 2014 12:49 PM EDT by Editor Ben Mahaney in Exclusively Published • Healthcare
In a research report issued today, Roth Capital analyst Ed Arce reiterated a Buy rating on BioCryst Pharmaceuticals (NASDAQ:BCRX) with a $20 price target, which represents a potential upside of 99% from where the stock is currently trading.
Arce wrote, “Within the next two weeks, BioCryst is expected to initiate OPuS-2, likely the first of two trials sufficient for an NDA submittal of BCX-4161, the only oral prophylactic treatment for the ultra-orphan disease HAE. Within the next week we are anticipating (assuming manufacturing issues are resolved) Rapivab will likely become the first IV drug approved for influenza. We continue to view BioCryst’s HAE portfolio as a pharmacological breakthrough that should ultimately dominate the therapeutic class with peak sales.”
The analyst added, “The approval of Rapivab upon its December 23rd PDUFA date is contingent on full resolution of the issues outlined in the FDA Warning Letter to BioCryst’s contract manufacturing organization (CMO) for Rapivab (peramivir). Nevertheless, even if Rapivab is not approved next week, we remain confident in its approvablity.”
"This could be the first bio in history that goes up with a negative FDA decision."
that's right…it'll be a "last call to cover" fest...
That's why I figure that they will have to defend the $11.50 level at all costs. That is unless they start to convert.
Even if Peramivab flops. The institutions that are here are long for HAE and understand the Peramivab situation. The rest of the outstanding is or has already been shorted, where is the BIG downside stock going to come from to crush the price?
This could be the first bio in history that goes up with a negative FDA decision.
Sentiment: Strong Buy