Search found 409 matches

by biopearl123
Sat Aug 08, 2020 6:48 pm
Forum: ImetelChat
Topic: Once in a while--hat tip to Fan YMB
Replies: 4
Views: 1356

Once in a while--hat tip to Fan YMB

Once in a while Fan on YMB comes up with some interesting information as a result of his or her diligent digging. In this case the following: https://8c3e11d9-5f36-452f-abe3-c95befd6e85d.filesusr.com/ugd/e1a359_3ce53a1d83e84d6d83866c55195d1056.pdf Check out the verbiage under "evidentiary requiremen...
by biopearl123
Tue Aug 04, 2020 10:03 pm
Forum: ImetelChat
Topic: No press release yet
Replies: 3
Views: 1544

No press release yet

The fact that EU orphan designation has been granted to MDS as anticipated in the PR of early July, this could be viewed as a formality but one I would think that warrants a press release rather than having the minions like us searching data bases to confirm this event. This suggests to me that addi...
by biopearl123
Sat Aug 01, 2020 7:49 pm
Forum: ImetelChat
Topic: EU orphan status
Replies: 12
Views: 2922

Re: EU orphan status

Ryan, I wish it were that straightforward. Get OD is a good thing but unless we see some glimmer of MA, the significance will be similar to the OD that was designated long ago in the US. For Fish’s sake and his work and thoughtfulness I hope this leads to MA in the EU soon but it’s still not a foreg...
by biopearl123
Fri Jul 31, 2020 6:43 pm
Forum: ImetelChat
Topic: Gilead bringing CAR-T to more blood cancers
Replies: 2
Views: 962

Re: Gilead bringing CAR-T to more blood cancers

Bill, some side effects can be pretty significant:
http://www.haematologica.org/content/ea ... l.pdf+html
by biopearl123
Tue Jul 28, 2020 12:02 am
Forum: ImetelChat
Topic: Gilead bringing CAR-T to more blood cancers
Replies: 2
Views: 962

Re: Gilead bringing CAR-T to more blood cancers

When asked directly about potential competition, the door was opened for a direct answer but one was not received (except for a nod to Constellation Pharma). Therefore I have to conclude that this therapy, while very promising (but expensive) does not pose an immediate threat. I think CAR-t has bigg...
by biopearl123
Mon Jul 27, 2020 11:57 pm
Forum: ImetelChat
Topic: EMA Jan 2016
Replies: 0
Views: 697

EMA Jan 2016

From the EMA when OD was granted for MF: "Designated orphan medicinal products are products that are still under investigation and are considered for orphan designation on the basis of potential activity. An orphan designation is not a marketing authorisation. As a consequence, demonstration of qual...
by biopearl123
Mon Jul 27, 2020 6:57 pm
Forum: ImetelChat
Topic: A question for the FDA
Replies: 4
Views: 1004

Re: A question for the FDA

Sorry about the Kamall, kmall, I know you better than most of the other posters but my spell check does not. bp
by biopearl123
Mon Jul 27, 2020 6:17 pm
Forum: ImetelChat
Topic: A question for the FDA
Replies: 4
Views: 1004

Re: A question for the FDA

Hi Kamall, sorry you had trouble posting before, as you know we have glitches with this site for reasons discussed previously. It was great to hear from you, I was afraid you had been blown off course and ended up on an island previously only inhabited by a FedEx guy. Thank you for your research and...
by biopearl123
Sun Jul 26, 2020 11:02 pm
Forum: ImetelChat
Topic: A question for the FDA
Replies: 4
Views: 1004

A question for the FDA

Recently an article in the Wall Street Journal highlighted a list of co morbid conditions that predisposed to death should a patient get COVID. The data was taken from the unimpeachable journal "Nature". The highest risk co morbidities list was headed by blood and bone marrow cancer. Higher risk tha...
by biopearl123
Sun Jul 26, 2020 10:29 pm
Forum: ImetelChat
Topic: I thought this was interesting:
Replies: 3
Views: 1320

Re: I thought this was interesting:

Hi Ashah, I think the jist of where I saw this going (perhaps because of an over active imagination) was that an application for Market Authorization in the EU has some mechanism to proceed in parallel to that of Orphan status. It does not appear that they necessarily have to occur in series. In a p...
by biopearl123
Thu Jul 16, 2020 6:45 pm
Forum: ImetelChat
Topic: Geron's universe continues to expand:
Replies: 1
Views: 875

Geron's universe continues to expand:

https://ir.geron.com/investors/press-re ... fault.aspx

One can only hope they are building a sales force but Dr. Scarlett has alluded to expanding research capabilities (in house lab research?).
by biopearl123
Wed Jul 15, 2020 2:47 am
Forum: ImetelChat
Topic: New BOD representation
Replies: 4
Views: 1250

Re: New BOD representation

Thank you CKTC for clarification. Does this arrangement "protect" the board's current composition and guard against a large investor's potential influence on decision making? These recent investors are pretty big hitters and to HI's point would likely wish to influence the company's direction. bp
by biopearl123
Tue Jul 14, 2020 5:57 pm
Forum: ImetelChat
Topic: Spontaneous remission in high risk MDS/AML
Replies: 3
Views: 1332

Re: Spontaneous remission in high risk MDS/AML

FC4364, Having an oral drug approved is definitely an important event but the Astex combination is approved for high risk MDS and CMML, a little bit of a different disease universe. So far I am not sure if there is overlap with the lower risk group that Imetelstat targets. I agree that no clinical n...
by biopearl123
Mon Jul 13, 2020 7:52 pm
Forum: ImetelChat
Topic: Spontaneous remission in high risk MDS/AML
Replies: 3
Views: 1332

Spontaneous remission in high risk MDS/AML

High risk MDS/AML has a rare spontaneous remission rate. Here is what I found so far: https://ashpublications.org/bloodadvances/article/3/18/2696/374950/Patients-with-spontaneous-remission-of-high-risk They report a 64 year period with 46 cases each a little different. Its pretty rare. Not too sure ...
by biopearl123
Mon Jul 13, 2020 7:39 pm
Forum: ImetelChat
Topic: New BOD representation
Replies: 4
Views: 1250

Re: New BOD representation

Is the ownership not limited to under 10% for each entity? Not sure if any one investor has the firepower to command a board seat but if they do, they would almost certainly try to monetize sooner. For us old guys that might be good but the full potential of the company might not be realized if a ta...
by biopearl123
Wed Jul 08, 2020 4:59 pm
Forum: ImetelChat
Topic: MDS approval for HM oral agent
Replies: 1
Views: 1135

Re: MDS approval for HM oral agent

rccola335, Good point about potential transmissibility of virus. Considering that other blood borne diseases like malaria, Chagas, HIV, prions etc can be transmitted, would not be surprised to see cases of COVID as well.
by biopearl123
Tue Jul 07, 2020 4:34 pm
Forum: ImetelChat
Topic: Use of RWD for frontline MF approval
Replies: 4
Views: 1980

Re: Use of RWD for frontline MF approval

Hi Ashah, I think the answer lies in Geron needing data to differentiate it from Luspatercept which they now clearly have. bp