Member Info for metis20

While Arpida was developing iclaprim, the FDA was re-evaluating the requirement for the non-inferiority margin to support approval of new antibiotics. The accepted non-inferiority margin when the ASSIST clinical trials initiated was -12.5%. However, in 2008 the FDA decided that compounds for the treatment of skin and skin structure infections required a non-inferiority margin of -10% instead of -12.5%.

When Arpida conducted the data analysis from the ASSIST trials the agreed upon non-inferiority margin was -12.5%, thus the company believed that the two trials each had positive outcomes.

Following submission of the NDA, the FDA “moved the goalposts” and evaluated the data for iclaprim using a non-inferiority margin of -10%, which was consistent with the revised guidelines.

The ASSIST-1 trial did not meet the -10% non-inferiority margin, and thus Arpida received a complete response letter (CRL) from the FDA. The FDA did not indicate that there were any concerns related to the way Arpida conducted the Phase 3 trials, however the agency did request that additional studies be conducted to demonstrate the effectiveness of iclaprim, which could include non-inferiority studies comparing iclaprim to an approved comparator.

Had Arpida been aware of the -10% non-inferiority margin requirement, the ASSIST trials likely would have been designed to include more patients in order to increase the statistical power.

Other Antibiotics With Similar Regulatory Pathway as Iclaprim
Iclaprim was not the only antibiotic to fall victim to the FDA altering the guidelines for non-inferiority testing in 2008. The FDA rejected oritavancin and dalbavancin each at approximately the same time as iclaprim based on clinical data that did not meet the 10% non-inferiority cutoff. However, both oritavancin and dalbavancin were studied in additional Phase 3 clinical trials (employing the same design as the REVIVE trials with vancomycin as the comparator) and each was approved for the treatment of ABSSSI in 2014. While some investors may be nervous about a compound that was previously rejected by the FDA, the fact that other antibiotics that were not approved for a similar reason as iclaprim have now gone on to be approved, should give investors confidence that Motif is
following the correct regulatory pathway for iclaprim.

above from -

http://s1.q4cdn.com/460208960/files/News/2017/Initiation_MTFB_Bautz.pdf

The 500k tombstone has just been moved to 40.5p......

That 500k on the ask at 41p has a time of 12:02:26.

That suggests it was removed just before the 12:00 auction and put back on to paint the board just after the noon auction...

Below from
https://www.thestreet.com/story/11635922/1/amarin-prepping-for-fda-approval-decision.html
may be of interest

What time will the FDA decision be announced?
Impossible to say. We may hear in the middle of the day, like we did Friday with Onyx Pharmaceuticals ( ONXX), or not until evening as with Vivus ( VVUS - Get Report). If you're trading the Amarin approval decision, my best advice is to be ready for news any time after noon EDT. And don't forget that Amarin may decide to halt trading at some point Thursday ahead of the announcement.

looks to be the CDER's communication process, not the FDA's

For FDA see

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page

No results have so far been published for today on

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page

Interesting to see at what time today's results are published. Likely to be when DOW has closed?

If so, the MTFB RNS is likely to be published 7am Thursday 14th

Reported shorts above 0.5% down from 7.5% (on 30 Jan) to 6.77% - five companies listed.

https://shorttracker.co.uk/company/GB00B8VZXT93/

MTFB sp has been held back by warrant drip feed - 20p warrants were still being exercised as late as last month.

Anyhow 2 years ago MTFB sp was in the low 20s so it has not done too badly prior to the imminent FDA decision.

Also STX has v good news at the end of last month...

a mere 113k at 32.2p

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/MTFB/13957932.html

From 18th Jan RNS

"Our sampling programme is progressing to plan and we are confident of reaching a long term off-take agreement with our potential off-take partner, which would generate significant revenue for Ironveld. I look forward to updating the market further in due course."

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/IRON/13938869.html

Figures may have been there for years but that is not the case for the recent lab work and scale up to the smelting trial results which are about to be reported.

Yes - it is wrong - currently 2.6/2.8p

The 32% drop was a fat finger episode. I bought 100k at 2.75p at 12:37 but it was published as being at 1.75p. These things do happen...

The 350k at 12:20 at 2.7p was a sell but at 12:55 there was 364k buy at 2.75p

Illiquid share and this was published on January 18th -

The Company has now delivered sufficient tonnage to the potential off-taker for them to undertake a full kiln smelting test and expects to receive the outcome of the test in the next three weeks following which the Company anticipates that a long term off-take agreement with the off-take partner will be reached.

3 weeks is up on Friday 8th feb.

On track to deliver its first human pharmacokinetic data in H1 2019

· MHRA clearance expected in February 2019 and patients scheduled for dosing in March 2019

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/NFX/13910579.html

Jangada Mines plc, a natural resources company developing South America's largest and most advanced platinum group metals ('PGM') and nickel project, has been informed that SilverStream SEZC ("SilverStream"), a dedicated precious metals streaming and royalty business with investments across Australasia, North and South America, has acquired the existing 1% Net Smelter Royalty ('NSR') on the Pedra Branca project from Solitario Zinc Corp. ("Solitario") (NYSE American: XPL; TSX: SLR). This was described by Silverstream as "the centrepiece" royalty in a transaction which included one other royalty and an option to purchase a third royalty for a total consideration of CAN$600,000.

Brian McMaster, Chairman of Jangada, said: "We are delighted to welcome Silverstream as a partner in the Pedra Branca project. SilverStream has recognised the value in Pedra Branca and this transaction is the latest step in the 3rd party validation of Pedra Branca as we advance through the verification stages of the BFS this quarter. The BFS team in South Africa and the project team in Brasil are working very hard at progressing the study and we are looking forward to another busy year."

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/JAN/13943363.html

Last placing was 24.2m shares at 1.65p November 19th 2018.

Friday's volume was 21.6m and about 14m traded between Nov 20th and last Thursday.

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/IRON/13871003.html

Approval can come before the PUDFA date -

"Another place to look is at PDUFA dates, and in doing so there is perhaps reason for cheer. During January and February there were 15 PDUFA dates, 3 of which resulted in Complete Response Letters and 12 of which were approvals, some of which not only occurred early, but very early. At least three of these were approved in December 2017, two months before the PDUFA date. Of the approvals during the first two months, 9 of them were NDAs and 6 were sNDAs."

http://eyeonfda.com/2018/03/pdufa-dates-adcomms-and-approvals-2018-so-far/

Ironveld's Vanadiferous Titaniferous Magnetite project has a resource that contains 27 million tons of HPI and 1.4 billion pounds of Vanadium in situ, the latter representing over four times the global annual demand.

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/IRON/13804532.html

" Following successful laboratory tests on samples of the Company's ore, the Off-taker has requested a sample of 10,000 tons for commercial scale testing (the "Commercial Sample"). "

above from

https://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/IRON/13804532.html

and from today's RNS

"The Company has now delivered sufficient tonnage to the potential off-taker for them to undertake a full kiln smelting test and expects to receive the outcome of the test in the next three weeks following which the Company anticipates that a long term off-take agreement with the off-take partner will be reached. "