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Fennec Pharmaceuticals Inc. (FRX.TO)
Toronto - Toronto Real Time Price. Currency in CAD
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At close: 09:37AM EDT
328 reactions on $FRX.TO conversation
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Anyone know who they are using as their manufacturer? Have those problems been fixed? Thinking of playing the upcoming pdufa.
There are people here promoting erroneous information about just how long a time frame will be involved in getting the manufacturing issues fixed, and it's not going to be a matter of weeks or even just a few months as some are saying! Here's the accurate regulatory guidance from the FDA, and note that FENC will have to submit a "Class 2 Resubmission," which once received can take as long as SIX MONTHS for FDA action:
. Note that among the factors that will require a Class 2 resubmission are "2. A new manufacturing facility(ies) or would warrant a follow-up assessment and/or inspection of manufacturing facility(ies);... ." See page 3, paragraph D. 2.
The business model of this company is to produce a pill. They intend to sell that pill north of $10,000. They look towards a 1 billion valuation.
So their entire production could fit in a large mayonnaise jar. Although they produced for the studies they now can't perform a minor production.
Its ok though. Although management won't explain what exactly the short comings are and infrequently communicates at all with share holders ... despite this we are to be confident share holders.
No more talk just post the inspection raw data. Is the facility missing a freezer or lab equipment.
I have been with a inspector at my old company. I know what the inspection sheet looks like. Produce that sheet
HC Wainwright initiated coverage with a $17 Price target. Very Undervalued. I think with data/news in December, January we see double digits very quickly. Strong Buy.
I don't care if it takes 1-2 years for approval if this gets in the $3 range I am loading up. It proved to get up to $10 right before approval and an average price forecast of $15 after approval. This company is only Pedmark so it needs to get approval. The whole focus for the next year will be on this issue. Once resolved an investment at this current entry will give you a 100% return preapproval and 275% from approval. I think it is worth an investment after we find the bottom. What do you think?
Another CRL for manufacturing issues. This could delay approval 6-9 months. Fennec will definitely need to raise more cash through stock sale or debt.
Confused about company's silence and FDA inability to clear manufacturing facility. Drug is viable and a ready made market, I would would think management would be more aggressive. So what's the deal?
Same thing happened to TRVN on Friday. It was going up and down. FDA announced approval at 7:49 PM or so. I keep checking their website for the news.
Drugs@FDA: FDA-Approved Drugs
Update from the CEO on the FDA's CRL
Listen to the Cantor Virtual Global Healthcare Conference webcast; lots of good Q&A from Cantor as well.
Cantor Virtual Global Healthcare Conference: Fennec Pharmaceuticals Inc.
Proved the point of stealth accumulation. Avoro Capoital Advisors took 1.6M position, while small pieces sold into the buy for the reason of limited upside. Look for major announcement in near term ahead of the tape based on this buy. Needs $9.39 to confirm with major run above $10.08. Based on FDA approval of mfg chain value of FENC should be $850M from current market cap of $206M.
For Long Term Investors... this is Coupon Day.
Just spoke with Fennec PR in Research Triangle...they anticipate the manufacturing "issue" a piece of plastic, irrelevant to the efficacy of treatment will be removed and re submitted in 1-2 weeks for final approval. Great news! I'm holding and buying. Who's with me?!
Let's also say a prayer that it is approved, so that kids undergoing Chemo don't run the risk of going deaf
Buy FENC. They will get approval next year and will get bought out $10-12 per share. Not being rumor monger about buyout. Read company transcripts and presentations. $10-12 might be low end. Stock should be about $6-7 today to reflect proper risk / reward.
Houston, we have a problem.
Announcement of FDA re-submission coming soon?
Big spike on heavy volume at end of the day...
Patience! 50% down is not appropriate reaction. Check the volume is only 3 million. No institution are selling. We should to review the new response letter before posting negative about the management. This is an opportunity for an entry, Institution ownership increased from 45% to 50%.
Cantor Virtual Global Healthcare Conference: Fennec Pharmaceuticals Inc. Tuesday, September 15, 2020
3:20 PM Eastern Time
so was the NDA ever submitted or do we still not know?
in 15 days the say what they will do to fix the facility and how long they need. Read up on the process before listening to bears trying to say it's a long time. this could be very short AND it doesnt have to do with the drug, so all potential upside that drives the stock price remains
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