FDA Calendar
May 11th, 2010 by BioRunUp
This FDA calendar is a free service to those who visit my site. Many other sites charge a fee, or at least require you to register, to view this information.
Regarding the entries in the calendar: 510K applications are based on an average 6 month response by the FDA, but this time frame is VERY flexible. Clinical Trial results are also an estimate. Not all Conference dates are entered.
Also, please note: I highly recommend any BioTech traders to get a paid membership to Mike Havrilla’s website, he publishes about 15-20 DAILY updates. You will make much more on undiscovered gems than the subscription fee costs. Use the promo code “mike5af7″ for 5% off a yearly subscription or “mike10af” to save 10% off a monthly subscription.
Thank you, and enjoy the calendar.
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| Monday | Tuesday | Wednesday | Thursday | Friday | Saturday | Sunday | ||||||||||||||||||||
| 1 * ANXANX Check ANX submission status |
2 |
3 |
4 |
5 |
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| 6 |
7 * FRXFRX FDA Panel for Ceftaroline. Partnered with AZN |
8 |
9 |
10 |
11 * QCORQCOR PDUFA |
12 |
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| 13 |
14 * SVNTSVNT PDUFA |
15 |
16 * ALKSALKS FDA Panel for Vivitrol * ARNAARNA FDA Panel |
17 |
18 |
19 * AZNAZN NDA for Brilinta |
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| 20 |
21 * NVSNVS NDA for Gilenia |
22 * BSDMBSDM 6 month estimated 510k date for MTX-180 |
23 |
24 * HOLXHOLX FDA Advisory Panel for breast cancer screening / diagnosis |
25 |
26 |
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| 27 |
28 |
29 |
30 * OSUROSUR ESTIMATE for PMA for Medical Device * BVXBVX 510k Submission for high-frequency electrosurgical generator (1450RF) designed for office use by physicians. 6 month ESTIMATE for 510ks * PODDPODD Time: 4:03 pm FDA Medical Device 6 month estime for OmniPod |
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Calendar developed and supported by Kieran O'Shea
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What happened to Biel.pk? it used to be on the Calendar?
Gregg
I had a complete website/ database failure and I had to rebuild the site from scratch. I have added BIEL back on to the calendar, on June 30th. Thank you for the heads up.
What happened to DDSS? it used to be on the Calendar last 2 months, Canada approval date on 04Aug2010 still valid?
It was deleted when we had hosting issues. It is back on the calendar now for 8/4
Canada approval date is coming very soon, but the price keeps running low everyday,i don’t get it. Looks like the method does not work for this time.
The Canada approval is not a very big catalyst for the stock. I stick with upcoming US FDA approvals.
Snts FDA Nda For Zegerid, Friday, 4/06/2010 is correct?…hummm
6/4 is a date they had for a trade name approval only, I clarified on the calendar.
You put now this in calendar, but ok!…Thanks, I like this site. This calendar is useful. It is important that information is correct.
congratulations
Yoko
Uluru has its annual meeting next Tuesday. There has been a big management shake-up as of last week with little if any information given. It should be an interesting meeting: does anyone know if they are going to have a conference call type set-up to listen-in to the meeting? If so, how or where does one go to access the meeting?
Your thoughts on BIEL? I bought
BIEL Monday, ahead
of the 510k. Thanks to this
calender I’m up already
40%
How about IMGG FDA is suppose to be some time between now and July?
I am not aware of any catalyst dates for IMGG in the near future.
What are your thoughts on the price of KOOL over the next month leading to the July 31 date?
KOOL, as with all 510K plays, is tough to call. Because of the lack of a FIRM date from the FDA the price is not as predicatable, but I see upward movement as we get closer to the July ESTIMATE. Overall market conditions will dictate KOOL now.
Reading up on THTCF it seems as though the chances of FDA approval are likely, what is your play based on the fact its a pink sheet. It is also trading very close to its 52week high…… do you have an opinion??
is NVS on 9/21 a NDA? I have it as a PDUFA for Gilenia
The PDUFA is the date, the NDA is the type of application. I double checked and it is on the calendar.
What is your opinion on Protalix. I am waiting for their confirmation of their PDUFA date.
Thanks Your Site is Great.
http://www.biorunup.com/542/plx-pdufa-date/
I was a member at Biomedreports for over 2 years, i had actually renewed my current my membership but by a totally random and lucky event my transaction was declined and I was not able to renew. (thank god)
I heard there was a special offer for members of that site.
I can provide any kind of proof you would require.
Cheers and thanks in advance.
Are you still following Exact Sciences (EXAS) ?
Annual meeting is Friday 7/16 and Validation results update is expected. We believe the day will be at a major event in Oct. or Nov. this year.
Thanks.
I am not in EXAS, but start a thread on the forum and we all can discuss it. Thanks!
http://www.biorunup.com/forum/clinical-trials-f46.html
Looks like you’re in it now…
I expect to double my $ in 90 days (Oct. 29th)
Looks like svnt has been moved to October 24? You See the same.
Do you have a link for that? According to SVNT’s website, it is still 9/14/10
Appears I came across bad information. Disregard.
Hi Mark,
probably better to remove PLX PDUFA date of Oct 27th to avoid confusion. Confirmed PDUFA is in Feb 25th, 2011.
Max
Monday: August 9th Conference Call ULURU Inc. 9:00 Am EDT. Discuss Altrazeal Ag., FDA 510 (k) status, EMA CE status, strategic alliances, update regarding adding inside and outside sales staff, update on China contract, call-in accepted. Call-in number available at company website http://www.uluru.com.
What do you think of HOLX run-up? Do you think it may be a good candidate?
What is a good exit point on CPIX?
Keep up the great website
Thanks,
VRX has made a nice runup over the last few weeks. i know it was on the calendar, but why no mention on the main page or forum? http://online.wsj.com/article/BT-CO-20100809-707844.html
Why is QCOR 11 sept. PDUFA not on the calendar?
I thought it was…. thanks- I just added it.
Wow, that was fast! Thanks!
Is QCOR a good candidate for run-up? When will the good entry point for QCOR be?
Thanks
Why hasnt CPIX run up very much? It’s no where near its 52 week high. You expecting a turn around?
Gregg
Does alexza not have an fad panel? Straight to pdufa?
Straight to the PDUFA
any news on BIEL???? whats happening over there?? Any FDA news
No news that I am aware of.
It is being reported today, that FDA has assigned 12/09/10 as HGSI Priority Review PDUFA for Benlysta.
I added it to the calendar, thx
ECPT has a pufda 12/29/10 or is that a pending event only?TIA!
Pending response from the FDA